HERACERAM— 510(k) K002993

Substantially Equivalent

J.F. Jelenko & Co., Inc.

FDA 510(k) clearance K002993 for HERACERAM, Substantially Equivalent on 2000-11-16. Applicant: J.F. Jelenko & Co., Inc.. Device class: 2.

Clearance details

Applicant: J.F. Jelenko & Co., Inc.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2000-09-25
Decision date: 2000-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Armonk, NY, US

Download summary PDF View on FDA.gov ↗

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