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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 K964238
Device Name AIRCAST VENA FLOW STERILE DISPOSABLE CUFFS
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 Received10/23/1996
Decision Date 09/08/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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