The following data is part of a premarket notification filed by Surgin Surgical Instrumentation, Inc. with the FDA for Suture Handler.
| Device ID | K934173 |
| 510k Number | K934173 |
| Device Name: | SUTURE HANDLER |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | SURGIN SURGICAL INSTRUMENTATION, INC. 14762 BENTLEY CIRCLE Tustin, CA 92680 |
| Contact | Don W Haar |
| Correspondent | Don W Haar SURGIN SURGICAL INSTRUMENTATION, INC. 14762 BENTLEY CIRCLE Tustin, CA 92680 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-26 |
| Decision Date | 1993-12-01 |