The following data is part of a premarket notification filed by Martin S. Knopf Assoc., Inc. with the FDA for H55 Hydrophilic Contact Lens.
| Device ID | K942214 |
| 510k Number | K942214 |
| Device Name: | H55 HYDROPHILIC CONTACT LENS |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | MARTIN S. KNOPF ASSOC., INC. 8 KINKEAD DR. Livingston, NJ 07039 |
| Contact | Martin S Knopf |
| Correspondent | Martin S Knopf MARTIN S. KNOPF ASSOC., INC. 8 KINKEAD DR. Livingston, NJ 07039 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-06 |
| Decision Date | 1994-07-28 |