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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 K170216
Device Name Flexitouch System
Applicant
Tactile Systems Technology, Inc (dba Tactile Medical)
1331 Tyler Street NE, Suite 200
Minneapolis,  MN  55413
Applicant Contact Thomas A. Dold
Correspondent
Tactile Systems Technology, Inc (dba Tactile Medical)
1331 Tyler Street NE, Suite 200
Minneapolis,  MN  55413
Correspondent Contact Thomas A. Dold
Regulation Number870.5800
Classification Product Code
JOW  
Subsequent Product Code
PPS  
Date Received01/24/2017
Decision Date 05/26/2017
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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