The following data is part of a premarket notification filed by Bio-vascular, Inc. with the FDA for Peri-strips Planar Configuration Staple Line Reinforcement.
Device ID | K942583 |
510k Number | K942583 |
Device Name: | PERI-STRIPS PLANAR CONFIGURATION STAPLE LINE REINFORCEMENT |
Classification | Mesh, Surgical, Polymeric |
Applicant | BIO-VASCULAR, INC. 2670 PATTON RD. Saint Paul, MN 55113 |
Contact | Bruce A Macfarlane, Ph.d |
Correspondent | Bruce A Macfarlane, Ph.d BIO-VASCULAR, INC. 2670 PATTON RD. Saint Paul, MN 55113 |
Product Code | FTL |
CFR Regulation Number | 878.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-06-01 |
Decision Date | 1994-07-08 |