The following data is part of a premarket notification filed by Bio-vascular, Inc. with the FDA for Ocu-guard Orbital Implant Wrap, Supple Ocu-guard Orbital Implant Wrap.
| Device ID | K973552 |
| 510k Number | K973552 |
| Device Name: | OCU-GUARD ORBITAL IMPLANT WRAP, SUPPLE OCU-GUARD ORBITAL IMPLANT WRAP |
| Classification | Wrap, Implant, Orbital |
| Applicant | BIO-VASCULAR, INC. 2575 UNIVERSITY AVE. St. Paul, MN 55114 -1024 |
| Contact | Julie Sherman |
| Correspondent | Julie Sherman BIO-VASCULAR, INC. 2575 UNIVERSITY AVE. St. Paul, MN 55114 -1024 |
| Product Code | MTZ |
| CFR Regulation Number | 886.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-19 |
| Decision Date | 1997-12-16 |
| Summary: | summary |