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