The following data is part of a premarket notification filed by Bausch & Lomb Pharmaceutical, Inc. with the FDA for Labeling Changes To Bio-cor Ext Collangen Corneal.
| Device ID | K884364 |
| 510k Number | K884364 |
| Device Name: | LABELING CHANGES TO BIO-COR EXT COLLANGEN CORNEAL |
| Classification | Collagen Corneal Shield |
| Applicant | BAUSCH & LOMB PHARMACEUTICAL, INC. 11300 49TH.STREET NORTH Clearwater, FL 34622 |
| Contact | H Duffell |
| Correspondent | H Duffell 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 | 1988-10-20 |
| Decision Date | 1988-11-29 |