The following data is part of a premarket notification filed by Chiron Ophthalmics with the FDA for Coi 24 Hr Collagen Shield.
| Device ID | K885016 |
| 510k Number | K885016 |
| Device Name: | COI 24 HR COLLAGEN SHIELD |
| Classification | Collagen Corneal Shield |
| Applicant | CHIRON OPHTHALMICS 9342 JERONIMO RD. Irvine, CA 92718 |
| Contact | Mcgarvey |
| Correspondent | 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 | 1988-12-05 |
| Decision Date | 1989-02-01 |