The following data is part of a premarket notification filed by Surgical Innovations Corp. with the FDA for Laparoscopic Mini-dissector/right Angle Retractor.
| Device ID | K914098 |
| 510k Number | K914098 |
| Device Name: | LAPAROSCOPIC MINI-DISSECTOR/RIGHT ANGLE RETRACTOR |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | SURGICAL INNOVATIONS CORP. 2545 CHICAGO AVE. SUITE 600 Minneapolis, MN 55404 |
| Contact | J Pietrafitta |
| Correspondent | J Pietrafitta SURGICAL INNOVATIONS CORP. 2545 CHICAGO AVE. SUITE 600 Minneapolis, MN 55404 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-12 |
| Decision Date | 1991-10-28 |