The following data is part of a premarket notification filed by Air Techniques, Inc. with the FDA for Vistacam Omni And Viastcam Omni (ic).
Device ID | K974204 |
510k Number | K974204 |
Device Name: | VISTACAM OMNI AND VIASTCAM OMNI (IC) |
Classification | Unit, Operative Dental |
Applicant | AIR TECHNIQUES, INC. 70 CANTIAGUE ROCK RD. Hicksville, NY 11802 |
Contact | Joseph Carey |
Correspondent | Joseph Carey AIR TECHNIQUES, INC. 70 CANTIAGUE ROCK RD. Hicksville, NY 11802 |
Product Code | EIA |
CFR Regulation Number | 872.6640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-11-10 |
Decision Date | 1998-01-08 |