BIO HERADOR SG, BIO HEADER GG, HERADOR S, BIO HERADOR N, HERABOND, HERALOY G, ALBABOND, BIO MAINGOLD SG, MAINGOLD SG, HE— 510(k) K003603

Name: FDA 510(k) clearance K003603
Creator: U.S. Food and Drug Administration
Published: 2001-01-10

Substantially Equivalent

Jelenko Co.

FDA 510(k) clearance K003603 for BIO HERADOR SG, BIO HEADER GG, HERADOR S, BIO HERADOR N, HERABOND, HERALOY G, ALBABOND, BIO MAINGOLD SG, MAINGOLD SG, HE, Substantially Equivalent on 2001-01-10. 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: 2000-11-21
Decision date: 2001-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Armonk, NY, US

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