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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 K961166
Device Name FLOWTRON EXCEL PUMP
Applicant
HNE HEALTHCARE, INC.
227 ROUTE 33 EAST
MANALAPAN,  NJ  07726
Applicant Contact AUDREY WITKO
Correspondent
HNE HEALTHCARE, INC.
227 ROUTE 33 EAST
MANALAPAN,  NJ  07726
Correspondent Contact AUDREY WITKO
Regulation Number870.5800
Classification Product Code
JOW  
Date Received03/25/1996
Decision Date 10/11/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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