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510(k) K812068

PROPOSED CONTROLS FOR DOSIMETRIC RELEASE by Hexcel Medical — Product Code LIB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 1981
Date Received
July 21, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, General Purpose, Microbiology, Diagnostic
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

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