- - - - - - - - - - DOCUMENT RECEIVED, FILED, & ACKNOWLEDGED - - - - - - - - - -
- DOCUMENT RECEIVED, FILED, & ACKNOWLEDGED - - - - - - - - - -
This automated notification from the CeSub Submission Process contains general information about the aforementioned submission:
Accession Number: 1820833-000
Date Loaded: Sep 17, 2018
Document Date: Sep 15, 2018
Establishment Name: DONGGUAN HELLEN ELECTRONIC TECHNOLOGY CO.,LTD
Purpose: This submission is a(n) Product Report. These Surveying, Leveling, Alignment Laser Products include designated model(s) HL-2165-01, HL-2165-02, HL-2165-03, HL-2165, HL-2165P.
Submitter: Tony Mo
Email: tonymo1@cct-prc.com
Reporting Official: Tony Mo
Email: tonymo1@cct-prc.com
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Please note that your firm is required to submit an Annual Report to CDRH every year by September 1.
If you meet all other applicable FDA requirements, you may market the product(s) reported. Please be aware that additional electronic product radiation control or medical device regulations may apply to your product, such as:
21 CFR 1002.11, requiring report supplements under certain circumstances following the same reporting forms as used for product reports on your products
21 CFR 1002.13, requiring annual reports to be submitted each year by September 1 using the appropriate reporting form for annual reports
21 CFR 1010 - 1050, requiring certification to FDA radiation safety performance standards
21 CFR 807, requiring manufacturer registration and device listing, and
21 CFR 807, 812 and 814, requiring medical device clearance or approval
For further information see:
Radiological Health web site - http://www.fda.gov/Radiation-EmittingProducts/default.htm
FDA Electronic Submissions Gateway website -
http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm
If you have any questions, please contact the Director of the Division of Radiological Health, or the branch chief of your respective product area, as listed on the CDRH Management Directory, under the Office of In Vitro Diagnostics and Radiological Health, Division of Radiological Health.
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHOffices/ucm127854.htm
Please include a primary (and optional secondary) contact email address in all submissions (and/or cover letters) to facilitate electronic correspondence.
Sincerely yours,
Division of Radiological Health
Office of In Vitro Diagnostics and Radiological Health
Center for Devices and Radiological Health