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 | K990480 |
510k Number | K990480 |
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 | 1999-02-16 |
Decision Date | 1999-05-10 |
Summary: | summary |