The following data is part of a premarket notification filed by Asi Medical, Inc. with the FDA for Airprep System - Model 9001.
Device ID | K974488 |
510k Number | K974488 |
Device Name: | AIRPREP SYSTEM - MODEL 9001 |
Classification | Airbrush |
Applicant | ASI MEDICAL, INC. 14550 EAST EASTER AVE. SUITE 700 Englewood, CO 80112 |
Contact | John W Mcpeek |
Correspondent | John W Mcpeek ASI MEDICAL, INC. 14550 EAST EASTER AVE. SUITE 700 Englewood, CO 80112 |
Product Code | KOJ |
CFR Regulation Number | 872.6080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-11-26 |
Decision Date | 1998-05-26 |