The following data is part of a premarket notification filed by Sds Dental, Inc. with the FDA for Jetsonic 2000.
Device ID | K990545 |
510k Number | K990545 |
Device Name: | JETSONIC 2000 |
Classification | Airbrush |
Applicant | SDS DENTAL, INC. 5101 N.W. 21ST AVE. N.W. SUITE 141 Fort Lauderdale, FL 33309 |
Contact | Cesar Coral |
Correspondent | Cesar Coral SDS DENTAL, INC. 5101 N.W. 21ST AVE. N.W. SUITE 141 Fort Lauderdale, FL 33309 |
Product Code | KOJ |
CFR Regulation Number | 872.6080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-02-22 |
Decision Date | 1999-08-11 |
Summary: | summary |