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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 K910188
Device Name FLOWPLUS AC330 PUMP GARMENTS
Applicant
HUNTLEIGH TECHNOLOGY, INC.
227 ROUTE 33 EAST
MANALAPAN,  NJ  07726
Applicant Contact AUDREY WITKO
Correspondent
HUNTLEIGH TECHNOLOGY, INC.
227 ROUTE 33 EAST
MANALAPAN,  NJ  07726
Correspondent Contact AUDREY WITKO
Regulation Number870.5800
Classification Product Code
JOW  
Date Received01/16/1991
Decision Date 05/28/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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