The following data is part of a premarket notification filed by Gm Engineering, Inc. with the FDA for Gm Swivel Video (tm) Irrigator.
| Device ID | K931398 |
| 510k Number | K931398 |
| Device Name: | GM SWIVEL VIDEO (TM) IRRIGATOR |
| Classification | Irrigator, Sinus |
| Applicant | GM ENGINEERING, INC. 2549 SIERRA WAY, SUITE B La Verne, CA 91750 |
| Contact | David Steffin |
| Correspondent | David Steffin GM ENGINEERING, INC. 2549 SIERRA WAY, SUITE B La Verne, CA 91750 |
| Product Code | KAR |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-19 |
| Decision Date | 1993-08-30 |