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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 K961676
Device Name AIRCAST VENAFLOW SYSTEM (MODIFICATION)
Applicant
Aircast, Inc.
P.O. Box 709
92 River Rd.
Summit,  NJ  07902 -0709
Applicant Contact STEPHEN L KENNEY
Correspondent
Aircast, Inc.
P.O. Box 709
92 River Rd.
Summit,  NJ  07902 -0709
Correspondent Contact STEPHEN L KENNEY
Regulation Number870.5800
Classification Product Code
JOW  
Date Received04/12/1996
Decision Date 03/28/1997
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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