ENCORE— 510(k) K915113

Substantially Equivalent

Heraeus Kulzer, Inc.

FDA 510(k) clearance K915113 for ENCORE, Substantially Equivalent on 1992-03-18. Applicant: Heraeus Kulzer, Inc.. Device class: 1.

Clearance details

Applicant: Heraeus Kulzer, Inc.
Product code: Code JJQ
Device class: Class 1
Regulation: 21 CFR 862.2300
Advisory panel: Clinical Chemistry
Date received: 1991-11-13
Decision date: 1992-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mishawaka, IN, US

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