FDA 510(k) Application Details - K203178

Device Classification Name	Sleeve, Limb, Compressible   More FDA Info for this Device
510(K) Number	K203178
Device Name	Sleeve, Limb, Compressible
Applicant	Tactile Systems Technology, Inc. (DBA Tactile Medical) 151 5th Ave NW Suite 100 New Brighton, MN 55112 US Other 510(k) Applications for this Company
Contact	Brett Demchuk Other 510(k) Applications for this Contact
Regulation Number	870.5800   More FDA Info for this Regulation Number
Classification Product Code	JOW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/26/2020
Decision Date	12/20/2020
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