The following data is part of a premarket notification filed by J.f. Jelenko & Co., Inc. with the FDA for Jeltemp.
| Device ID | K991564 |
| 510k Number | K991564 |
| Device Name: | JELTEMP |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | J.F. JELENKO & CO., INC. 99 BUSINESS PARK DR. Armonk, NY 10504 |
| Contact | Raphael Judkins |
| Correspondent | Raphael Judkins J.F. JELENKO & CO., INC. 99 BUSINESS PARK DR. Armonk, NY 10504 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-05 |
| Decision Date | 1999-06-23 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() JELTEMP 75611531 2616160 Dead/Cancelled |
HERAEUS-KULZER, INC. 1998-12-23 |