The following data is part of a premarket notification filed by Vitaphore Corp. with the FDA for Collagen Shield For Acute Care.
| Device ID | K902558 |
| 510k Number | K902558 |
| Device Name: | COLLAGEN SHIELD FOR ACUTE CARE |
| Classification | Collagen Corneal Shield |
| Applicant | VITAPHORE CORP. 1505 O'BRIEN DR. Menlo Park, CA 94025 |
| Contact | Jan Tomsic |
| Correspondent | Jan Tomsic VITAPHORE CORP. 1505 O'BRIEN DR. Menlo Park, CA 94025 |
| Product Code | MOE |
| CFR Regulation Number | 886.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-11 |
| Decision Date | 1990-08-17 |