PROPOSED CONTROLS FOR DOSIMETRIC RELEASE— 510(k) K812068

Name: FDA 510(k) clearance K812068
Creator: U.S. Food and Drug Administration
Published: 1981-09-08

Substantially Equivalent

Hexcel Medical

FDA 510(k) clearance K812068 for PROPOSED CONTROLS FOR DOSIMETRIC RELEASE, Substantially Equivalent on 1981-09-08. Applicant: Hexcel Medical. Device class: 1.

Clearance details

Applicant: Hexcel Medical
Product code: Code LIB
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1981-07-21
Decision date: 1981-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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