The following data is part of a premarket notification filed by Bio-vascular, Inc. with the FDA for Peri-guard, Cv Peri-guard, Ocu-guard, Supple Peri-guard, Peri-strips - Sleeve, Peri-strips-strips, Peri-strips Dry, Vasc.
| Device ID | K983162 |
| 510k Number | K983162 |
| Device Name: | PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, PERI-STRIPS-STRIPS, PERI-STRIPS DRY, VASC |
| Classification | Mesh, Surgical |
| 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 | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-10 |
| Decision Date | 1998-10-09 |
| Summary: | summary |