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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 K881632
Device Name FLOWTRON DVT SYSTEM AC500 PUMP, L501 GARMENT
Applicant
HUNTLEIGH TECHNOLOGY, INC.
227 ROUTE 33 EAST
MANALAPAN,  NJ  07726
Applicant Contact JAMES BRITTON
Correspondent
HUNTLEIGH TECHNOLOGY, INC.
227 ROUTE 33 EAST
MANALAPAN,  NJ  07726
Correspondent Contact JAMES BRITTON
Regulation Number870.5800
Classification Product Code
JOW  
Date Received04/14/1988
Decision Date 09/26/1988
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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