K-number	K770808
Device name	RESP. SYNCYTIAL-FA LABELLED PRESERUM
Applicant	Flow Laboratories, Inc.
Product code	GQG
Device class	Class I
Decision date	May 20, 1977
Decision	Substantially Equivalent
Regulation	866.3480

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View the full FDA submission: accessdata.fda.gov

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RESP. SYNCYTIAL-FA LABELLED PRESERUM

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