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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 K071763
Device Name AMADEUS ADAPTIVE COMPRESSION THERAPY
Applicant
Convatec
200 Headquarters Park Dr.
Skillman,  NJ  08558
Applicant Contact MARILYN KONICKY
Correspondent
Convatec
200 Headquarters Park Dr.
Skillman,  NJ  08558
Correspondent Contact MARILYN KONICKY
Regulation Number870.5800
Classification Product Code
JOW  
Date Received06/29/2007
Decision Date 03/07/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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