HERACERAM 75— 510(k) K010416

Substantially Equivalent

Jelenko Co.

FDA 510(k) clearance K010416 for HERACERAM 75, Substantially Equivalent on 2001-03-08. Applicant: Jelenko Co.. Device class: 2.

Clearance details

Applicant: Jelenko Co.
Product code: Code EJT
Device class: Class 2
Regulation: 21 CFR 872.3060
Advisory panel: Dental
Date received: 2001-02-12
Decision date: 2001-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Armonk, NY, US

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