The following data is part of a premarket notification filed by Gm Engineering, Inc. with the FDA for Articulating Retractor Tissue Retractors.
| Device ID | K953348 |
| 510k Number | K953348 |
| Device Name: | ARTICULATING RETRACTOR TISSUE RETRACTORS |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | GM ENGINEERING, INC. 2549 SIERRA WAY, SUITE B La Verne, CA 91750 |
| Contact | Jared K Larsen |
| Correspondent | Jared K Larsen GM ENGINEERING, INC. 2549 SIERRA WAY, SUITE B La Verne, CA 91750 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-17 |
| Decision Date | 1995-09-12 |