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 |