The following data is part of a premarket notification filed by Kreativ, Inc. with the FDA for Kreativ Mach 5, Mach 5 Plus, Mach M, Mach 6.
Device ID | K980216 |
510k Number | K980216 |
Device Name: | KREATIV MACH 5, MACH 5 PLUS, MACH M, MACH 6 |
Classification | Airbrush |
Applicant | KREATIV, INC. 1517 INDUSTRIAL WAY, S.W. Albany, OR 97321 |
Contact | Joe Forehand |
Correspondent | Joe Forehand KREATIV, INC. 1517 INDUSTRIAL WAY, S.W. Albany, OR 97321 |
Product Code | KOJ |
CFR Regulation Number | 872.6080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-01-21 |
Decision Date | 1998-06-16 |
Summary: | summary |