The following data is part of a premarket notification filed by Chiron Ophthalmics with the FDA for Collagen Shield, Various Models.
| Device ID | K905825 |
| 510k Number | K905825 |
| Device Name: | COLLAGEN SHIELD, VARIOUS MODELS |
| Classification | Collagen Corneal Shield |
| Applicant | CHIRON OPHTHALMICS 9342 JERONIMO RD. Irvine, CA 92718 |
| Contact | S. K Mcgarvey |
| Correspondent | S. K Mcgarvey CHIRON OPHTHALMICS 9342 JERONIMO RD. Irvine, CA 92718 |
| Product Code | MOE |
| CFR Regulation Number | 886.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-31 |
| Decision Date | 1991-06-10 |