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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 K143185
Device Name entré Model PD08-U
Applicant
Tactile Systems Technology, Inc.
1331 Tyler St. N.E
Minneapolis,  MN  55413
Applicant Contact DANIEL G CHASE
Correspondent
Tactile Systems Technology, Inc.
1331 Tyler St. N.E
Minneapolis,  MN  55413
Correspondent Contact DANIEL G CHASE
Regulation Number870.5800
Classification Product Code
JOW  
Date Received11/05/2014
Decision Date 05/07/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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