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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name sleeve, limb, compressible
510(k) Number K024019
Device Name ARTERIALFLOW SYSTEM, MODEL 32A
Applicant
AIRCAST, INC.
92 RIVER RD.
SUMMIT,  NJ  07902
Applicant Contact STEPHEN L KENNEY
Correspondent
AIRCAST, INC.
92 RIVER RD.
SUMMIT,  NJ  07902
Correspondent Contact STEPHEN L KENNEY
Regulation Number870.5800
Classification Product Code
JOW  
Date Received12/05/2002
Decision Date 06/03/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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