The following data is part of a premarket notification filed by Bio-vascular, Inc. with the FDA for Peri-strips Dry - Staple Line Reinforcement.
Device ID | K971048 |
510k Number | K971048 |
Device Name: | PERI-STRIPS DRY - STAPLE LINE REINFORCEMENT |
Classification | Mesh, Surgical |
Applicant | BIO-VASCULAR, INC. 2575 UNIVERSITY AVE. St. Paul, MN 55114 -1024 |
Contact | Barbara Atzenhoefer |
Correspondent | Barbara Atzenhoefer 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 | 1997-03-21 |
Decision Date | 1997-05-09 |
Summary: | summary |