The following data is part of a premarket notification filed by J.f. Jelenko & Co., Inc. with the FDA for Heraceram.
Device ID | K002993 |
510k Number | K002993 |
Device Name: | HERACERAM |
Classification | Powder, Porcelain |
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 | EIH |
CFR Regulation Number | 872.6660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-09-25 |
Decision Date | 2000-11-16 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
J0146605529110 | K002993 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
HERACERAM 76143634 2714958 Dead/Cancelled |
HERAEUS KULZER GMBH 2000-10-10 |
HERACERAM 76121924 2623218 Live/Registered |
KULZER GMBH 2000-09-05 |