The following data is part of a premarket notification filed by Bio-vascular, Inc. with the FDA for Peri-strips-sleeve, Peri-strips-strip And Peri-strips Dry (non-naoh-treated And Naoh-treated.
| Device ID | K992537 |
| 510k Number | K992537 |
| Device Name: | PERI-STRIPS-SLEEVE, PERI-STRIPS-STRIP AND PERI-STRIPS DRY (NON-NAOH-TREATED AND NAOH-TREATED |
| Classification | Mesh, Surgical |
| Applicant | BIO-VASCULAR, INC. 2575 UNIVERSITY AVE. St. Paul, MN 55114 -1024 |
| Contact | Mary Kay Kessinger Sobcinski |
| Correspondent | Mary Kay Kessinger Sobcinski BIO-VASCULAR, INC. 2575 UNIVERSITY AVE. St. Paul, MN 55114 -1024 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-29 |
| Decision Date | 2000-02-22 |
| Summary: | summary |