K-number	K792476
Device name	HELENA FACTOR XI DEFICIENT SUBSTRATE
Applicant	Helena Laboratories
Product code	GGP
Device class	Class II
Decision date	Dec 31, 1979
Decision	Substantially Equivalent
Regulation	864.7290

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Source

View the full FDA submission: accessdata.fda.gov

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HELENA FACTOR XI DEFICIENT SUBSTRATE

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