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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 -3327
Applicant Contact AUDRY WITKO
Correspondent
HUNTLEIGH HEALTHCARE, INC.
40 CHRISTOPHER WAY
EATONTOWN,  NJ  07724 -3327
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
Recalls CDRH Recalls
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