The following data is part of a premarket notification filed by Bausch & Lomb Healthcare And Optics Worldwide with the FDA for Bio-cor Collagen Corneal Shield.
| Device ID | K944872 |
| 510k Number | K944872 |
| Device Name: | BIO-COR COLLAGEN CORNEAL SHIELD |
| Classification | Collagen Corneal Shield |
| Applicant | BAUSCH & LOMB HEALTHCARE AND OPTICS WORLDWIDE 8500 HIDDEN RIVER PKWY. Tampa, FL 33637 |
| Contact | Brenda Minno |
| Correspondent | Brenda Minno BAUSCH & LOMB HEALTHCARE AND OPTICS WORLDWIDE 8500 HIDDEN RIVER PKWY. Tampa, FL 33637 |
| Product Code | MOE |
| CFR Regulation Number | 886.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-03 |
| Decision Date | 1995-07-26 |