The following data is part of a premarket notification filed by Alcon Laboratories with the FDA for Opti-free Supraclens Daily Protein Remover.
| Device ID | K974625 |
| 510k Number | K974625 |
| Device Name: | OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER |
| Classification | Accessories, Soft Lens Products |
| Applicant | ALCON LABORATORIES 6201 SOUTH FREEWAY R7-14 Fort Worth, TX 76134 -2099 |
| Contact | Ralph H Larsen |
| Correspondent | Ralph H Larsen ALCON LABORATORIES 6201 SOUTH FREEWAY R7-14 Fort Worth, TX 76134 -2099 |
| Product Code | LPN |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-11 |
| Decision Date | 1998-03-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00300650285445 | K974625 | 000 |