The following data is part of a premarket notification filed by Marlin Industries with the FDA for Marlin Soft Lens Handler.
| Device ID | K850984 |
| 510k Number | K850984 |
| Device Name: | MARLIN SOFT LENS HANDLER |
| Classification | Inserter/remover Contact Lens |
| 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 | KYE |
| CFR Regulation Number | 886.5420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-11 |
| Decision Date | 1985-09-10 |