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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 K932900
Device Name AIRCAST VENAFLOW SYSTEM
Applicant
AIRCAST, INC.
P.O. BOX 709
92 RIVER ROAD
SUMMIT,  NJ  07902 -0709
Applicant Contact JOHNSON JR.
Correspondent
AIRCAST, INC.
P.O. BOX 709
92 RIVER ROAD
SUMMIT,  NJ  07902 -0709
Correspondent Contact JOHNSON JR.
Regulation Number870.5800
Classification Product Code
JOW  
Date Received06/14/1993
Decision Date 10/25/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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