The following data is part of a premarket notification filed by Gm Engineering, Inc. with the FDA for True Flow(tm) Valve.
| Device ID | K930611 |
| 510k Number | K930611 |
| Device Name: | TRUE FLOW(TM) VALVE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | GM ENGINEERING, INC. 2549 SIERRA WAY, SUITE B La Verne, CA 91750 |
| Contact | Denny E Miles |
| Correspondent | Denny E Miles GM ENGINEERING, INC. 2549 SIERRA WAY, SUITE B La Verne, CA 91750 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-05 |
| Decision Date | 1993-12-01 |