The following data is part of a premarket notification filed by Marlin Industries with the FDA for Marlin Contact Lens Case.
Device ID | K851497 |
510k Number | K851497 |
Device Name: | MARLIN CONTACT LENS CASE |
Classification | Lens, Contact (polymethylmethacrylate) |
Applicant | MARLIN INDUSTRIES P.O. BOX 284 Tarzana, CA 91356 |
Contact | Jerome Hirsch |
Correspondent | Jerome Hirsch MARLIN INDUSTRIES P.O. BOX 284 Tarzana, CA 91356 |
Product Code | HPX |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-04-15 |
Decision Date | 1985-05-16 |