K-number	K812068
Device name	PROPOSED CONTROLS FOR DOSIMETRIC RELEASE
Applicant	Hexcel Medical
Product code	LIB
Device class	Class I
Decision date	Sep 8, 1981
Decision	Substantially Equivalent
Regulation	866.2660

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View the full FDA submission: accessdata.fda.gov

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PROPOSED CONTROLS FOR DOSIMETRIC RELEASE

Everything you need for a 510(k) submission. Nothing you don't.