Name: Predicase
Price: 199 USD

K-number	K962495
Device name	INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING HEMOSTATIC VALVE)
Applicant	Advanced Cardiovascular Systems, Inc.
Product code	MAV
Device class	Class II
Decision date	Sep 12, 1996
Decision	Substantially Equivalent
Regulation	870.1650

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Source

View the full FDA submission: accessdata.fda.gov

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INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING HEMOSTATIC VALVE)

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