FDA 510(k) Application Details - K961471

Device Classification Name Syringe, Balloon Inflation

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510(K) Number K961471
Device Name Syringe, Balloon Inflation
Applicant ADVANCED CARDIOVASCULAR SYSTEMS, INC.
3200 LAKESIDE DR.
SANTA CLARA, CA 95052-8167 US
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Contact GARY JOHNSON
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Regulation Number 870.1650

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Classification Product Code MAV
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Date Received 04/17/1996
Decision Date 05/08/1996
Decision SESK - SUBST EQUIV - KIT
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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