The following data is part of a premarket notification filed by Bio-vascular, Inc. with the FDA for Ocu-guard And Ocu-guard Supple.
| Device ID | K983581 |
| 510k Number | K983581 |
| Device Name: | OCU-GUARD AND OCU-GUARD SUPPLE |
| Classification | Implant, Orbital, Extra-ocular |
| Applicant | BIO-VASCULAR, INC. 2575 UNIVERSITY AVE. St. Paul, MN 55114 -1024 |
| Contact | Dianna L Geck |
| Correspondent | Dianna L Geck BIO-VASCULAR, INC. 2575 UNIVERSITY AVE. St. Paul, MN 55114 -1024 |
| Product Code | HQX |
| CFR Regulation Number | 886.3340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-13 |
| Decision Date | 1998-11-06 |
| Summary: | summary |