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 IDK002993
510k NumberK002993
Device Name:HERACERAM
ClassificationPowder, Porcelain
Applicant J.F. JELENKO & CO., INC. 99 BUSINESS PARK DR. Armonk,  NY  10504
ContactRaphael Judkins
CorrespondentRaphael Judkins
J.F. JELENKO & CO., INC. 99 BUSINESS PARK DR. Armonk,  NY  10504
Product CodeEIH  
CFR Regulation Number872.6660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-09-25
Decision Date2000-11-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
J0146605529110 K002993 000

Trademark Results [HERACERAM]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HERACERAM
HERACERAM
76143634 2714958 Dead/Cancelled
HERAEUS KULZER GMBH
2000-10-10
HERACERAM
HERACERAM
76121924 2623218 Live/Registered
KULZER GMBH
2000-09-05

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