DOSIMETRY RELEASE OF RADIATION STERILIZ— 510(k) K831512

Name: FDA 510(k) clearance K831512
Creator: U.S. Food and Drug Administration
Published: 1983-09-29

Substantially Equivalent

Biomet, Inc.

FDA 510(k) clearance K831512 for DOSIMETRY RELEASE OF RADIATION STERILIZ, Substantially Equivalent on 1983-09-29. Applicant: Biomet, Inc.. Device class: 2.

Clearance details

Applicant: Biomet, Inc.
Product code: Code JDK
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 1983-05-12
Decision date: 1983-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.