The following data is part of a premarket notification filed by Bausch & Lomb, Inc. with the FDA for Bio-cor Ext Collagen Corneal Shield.
| Device ID | K874225 |
| 510k Number | K874225 |
| Device Name: | BIO-COR EXT COLLAGEN CORNEAL SHIELD |
| Classification | Collagen Corneal Shield |
| Applicant | BAUSCH & LOMB, INC. 11300 49TH STREET, NORTH Clearwater, FL 34622 |
| Contact | Michael Stevens |
| Correspondent | Michael Stevens BAUSCH & LOMB, 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 | 1987-10-16 |
| Decision Date | 1988-01-22 |