Name: Predicase
Price: 199 USD

K-number	K961471
Device name	INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE)
Applicant	Advanced Cardiovascular Systems, Inc.
Product code	MAV
Device class	Class II
Decision date	May 8, 1996
Decision	Unknown
Regulation	870.1650

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Source

View the full FDA submission: accessdata.fda.gov

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INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE)

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