The following data is part of a premarket notification filed by Bausch & Lomb Pharmaceutical, Inc. with the FDA for Addit. Indications For Bio-cor Ii Collagen Corneal.
| Device ID | K884961 |
| 510k Number | K884961 |
| Device Name: | ADDIT. INDICATIONS FOR BIO-COR II COLLAGEN CORNEAL |
| Classification | Collagen Corneal Shield |
| Applicant | BAUSCH & LOMB PHARMACEUTICAL, INC. 11300 49TH.STREET NORTH Clearwater, FL 34622 |
| Contact | Duffell, Phd |
| Correspondent | Duffell, Phd BAUSCH & LOMB PHARMACEUTICAL, INC. 11300 49TH.STREET NORTH Clearwater, FL 34622 |
| Product Code | MOE |
| CFR Regulation Number | 886.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-18 |
| Decision Date | 1989-02-13 |