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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 K993758
Device Name PROAIR 3000 COMPRESSION SYSTEM
Applicant
Medical Compression Systems (Dbn) , Ltd.
117 Ahuzah St.
Ra'Ananna 43373,  IL 43373
Applicant Contact SHOSHANA FRIEDMAN
Correspondent
Medical Compression Systems (Dbn) , Ltd.
117 Ahuzah St.
Ra'Ananna 43373,  IL 43373
Correspondent Contact SHOSHANA FRIEDMAN
Regulation Number870.5800
Classification Product Code
JOW  
Date Received11/05/1999
Decision Date 05/19/2000
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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