The following data is part of a premarket notification filed by Kis Products with the FDA for Dispo Etch.
Device ID | K984380 |
510k Number | K984380 |
Device Name: | DISPO ETCH |
Classification | Airbrush |
Applicant | KIS PRODUCTS 2318 SEA ISLAND DR. Ft. Lauderdale, FL 33301 |
Contact | Reuben Hertz |
Correspondent | Reuben Hertz KIS PRODUCTS 2318 SEA ISLAND DR. Ft. Lauderdale, FL 33301 |
Product Code | KOJ |
CFR Regulation Number | 872.6080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-12-08 |
Decision Date | 2001-08-06 |