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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 K062818
Device Name FLEXITOUCH SYSTEM
Applicant
TACTILE SYSTEMS TECHNOLOGY INC
4824 PARK GLEN RD.
MINNEAPOLIS,  MN  55416
Applicant Contact PHILLIP R ROSE
Correspondent
INTERTEK TESTING SERVICES
2307 EAST AURORA ROAD
UNIT B7
TWINSBURG,  OH  44087
Correspondent Contact NEIL E DEVINE
Regulation Number870.5800
Classification Product Code
JOW  
Subsequent Product Code
IRP  
Date Received09/20/2006
Decision Date 10/06/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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