The following data is part of a premarket notification filed by Performance Surgical Instruments Corp. with the FDA for Lasso (schwaitzberg) Suture Snare.
| Device ID | K934737 |
| 510k Number | K934737 |
| Device Name: | LASSO (SCHWAITZBERG) SUTURE SNARE |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | PERFORMANCE SURGICAL INSTRUMENTS CORP. 40 NORFOLK AVE. South Easton, MA 02375 |
| Contact | Russell Holmes |
| Correspondent | Russell Holmes PERFORMANCE SURGICAL INSTRUMENTS CORP. 40 NORFOLK AVE. South Easton, MA 02375 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-01 |
| Decision Date | 1994-03-09 |