The following data is part of a premarket notification filed by Deldent Ltd. with the FDA for Jetstream.
Device ID | K014252 |
510k Number | K014252 |
Device Name: | JETSTREAM |
Classification | Airbrush |
Applicant | DELDENT LTD. 19 KEREN KAYEMET ST. Petach Tikvah, IL 49372 |
Contact | Alan Edel |
Correspondent | Alan Edel DELDENT LTD. 19 KEREN KAYEMET ST. Petach Tikvah, IL 49372 |
Product Code | KOJ |
CFR Regulation Number | 872.6080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-12-26 |
Decision Date | 2002-02-19 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07290016281842 | K014252 | 000 |