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 |