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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 K023800
Device Name VENAFLOW REUSABLE CALF AIRCELL, MODEL 3018, VENAFLOW DISPOSABLE CALF COVER, MODEL 3017
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 Received11/14/2002
Decision Date 02/10/2003
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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