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 |