The following data is part of a premarket notification filed by Oasis Medical, Inc. with the FDA for Softshield(tm) 12, 24, 72 Collagen Corneal Shields.
| Device ID | K914529 |
| 510k Number | K914529 |
| Device Name: | SOFTSHIELD(TM) 12, 24, 72 COLLAGEN CORNEAL SHIELDS |
| Classification | Collagen Corneal Shield |
| Applicant | OASIS MEDICAL, INC. 514 S. VERMONT AVE. Glendora, CA 91741 |
| Contact | James Christensen |
| Correspondent | James Christensen OASIS MEDICAL, INC. 514 S. VERMONT AVE. Glendora, CA 91741 |
| Product Code | MOE |
| CFR Regulation Number | 886.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-11 |
| Decision Date | 1991-11-13 |