FDA 510(k) Application Details - K131193

Device Classification Name Sleeve, Limb, Compressible

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510(K) Number K131193
Device Name Sleeve, Limb, Compressible
Applicant TACTILE SYSTEMS TECHNOLOGY INC
1331 Tyler St NE Ste 200
MINNEAPOLIS, MN 55413 US
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Contact DAVE HALVERSON
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Regulation Number 870.5800

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Classification Product Code JOW
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Date Received 04/26/2013
Decision Date 06/18/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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