The following data is part of a premarket notification filed by Air Techniques, Inc. with the FDA for Air Techniques' Dento-vac.
Device ID | K984584 |
510k Number | K984584 |
Device Name: | AIR TECHNIQUES' DENTO-VAC |
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 | 1998-12-24 |
Decision Date | 1999-03-22 |