The following data is part of a premarket notification filed by Omni-tract Surgical, Div. Minn. Scientific, Inc. with the FDA for Abdominal Wall Retractor.
| Device ID | K950214 |
| 510k Number | K950214 |
| Device Name: | ABDOMINAL WALL RETRACTOR |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | OMNI-TRACT SURGICAL, DIV. MINN. SCIENTIFIC, INC. 1100 NEW BRIGHTON BLVD. Minneapolis, MN 55413 -1660 |
| Contact | Steve Levahn |
| Correspondent | Steve Levahn OMNI-TRACT SURGICAL, DIV. MINN. SCIENTIFIC, INC. 1100 NEW BRIGHTON BLVD. Minneapolis, MN 55413 -1660 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-19 |
| Decision Date | 1995-02-06 |