The following data is part of a premarket notification filed by Simplex Medical Systems, Inc. with the FDA for Simplex Airbrator.
Device ID | K970249 |
510k Number | K970249 |
Device Name: | SIMPLEX AIRBRATOR |
Classification | Airbrush |
Applicant | SIMPLEX MEDICAL SYSTEMS, INC. 430 ANSIN BLVD. SUITE G Hallandale, FL 33009 |
Contact | John E Trafton |
Correspondent | John E Trafton SIMPLEX MEDICAL SYSTEMS, INC. 430 ANSIN BLVD. SUITE G Hallandale, FL 33009 |
Product Code | KOJ |
CFR Regulation Number | 872.6080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-01-22 |
Decision Date | 1997-05-07 |