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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name sleeve, head and neck, compressible
510(k) Number K153311
Device Name Flexitouch System
Applicant
TACTILE SYSTEMS TECHNOLOGY INC (DBA TACTILE MEDICAL)
1331 Tyler St NE, Ste 200
MINNEAPOLIS,  MN  55413
Applicant Contact Thomas A Dold
Correspondent
TACTILE SYSTEMS TECHNOLOGY INC (DBA TACTILE MEDICAL)
1331 Tyler St NE, Ste 200
MINNEAPOLIS,  MN  55413
Correspondent Contact Thomas A Dold
Regulation Number870.5800
Classification Product Code
PPS  
Subsequent Product Code
JOW  
Date Received11/17/2015
Decision Date 09/14/2016
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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