The following data is part of a premarket notification filed by Air Techniques, Inc. with the FDA for Air Techniques' Airdent Ii.
Device ID | K981564 |
510k Number | K981564 |
Device Name: | AIR TECHNIQUES' AIRDENT II |
Classification | Airbrush |
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 | KOJ |
CFR Regulation Number | 872.6080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-05-01 |
Decision Date | 1998-09-24 |