The following data is part of a premarket notification filed by Deldent Ltd. with the FDA for Jetsonic 2000.
| Device ID | K014245 |
| 510k Number | K014245 |
| Device Name: | JETSONIC 2000 |
| 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 | 2002-01-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016281996 | K014245 | 000 |