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 |