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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 K003857
Device Name STERILMED INTERMITTENT COMPRESSION SYSTEM, GARMENT MODELS 400 SERIES
Applicant
STERILMED, INC.
3650 ANNAPOLIS LN. NORTH
SUITE 170
PLYMOUTH,  MN  55447
Applicant Contact PATRICK FLEISCHHACKER
Correspondent
STERILMED, INC.
3650 ANNAPOLIS LN. NORTH
SUITE 170
PLYMOUTH,  MN  55447
Correspondent Contact PATRICK FLEISCHHACKER
Regulation Number870.5800
Classification Product Code
JOW  
Date Received12/13/2000
Decision Date 10/18/2001
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
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