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 |