HERACERAM
Powder, Porcelain
J.F. JELENKO & CO., INC.
The following data is part of a premarket notification filed by J.f. Jelenko & Co., Inc. with the FDA for Heraceram.
Pre-market Notification Details
| 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 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| J0146605529110 | K002993 | 000 |
Trademark Results [HERACERAM]
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 |
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