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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 K010744
Device Name FLOWTRON UNIVERSAL, MODEL AC600
Applicant
Huntleigh Healthcare, Inc.
40 Christopher Way
Eatontown,  NJ  07724
Applicant Contact AUDRY WITKO
Correspondent
Huntleigh Healthcare, Inc.
40 Christopher Way
Eatontown,  NJ  07724
Correspondent Contact AUDRY WITKO
Regulation Number870.5800
Classification Product Code
JOW  
Date Received03/13/2001
Decision Date 03/26/2002
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
Recalls CDRH Recalls
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