K-number	K113822
Device name	QUADRASPHERE 30 TO 60
Applicant	Biosphere Medical, Inc.
Product code	HCG
Device class	Class II
Decision date	Mar 8, 2012
Decision	Substantially Equivalent
Regulation	882.5950

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Source

View the full FDA submission: accessdata.fda.gov

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QUADRASPHERE 30 TO 60

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