FDA 510(k) Application Details - K193476

Device Classification Name	Sleeve, Limb, Compressible   More FDA Info for this Device
510(K) Number	K193476
Device Name	Sleeve, Limb, Compressible
Applicant	SLK Medical GmbH Oberste-Wilms-Str. 15a Dortmund 44309 DE Other 510(k) Applications for this Company
Contact	Matthew Reid 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	12/16/2019
Decision Date	08/19/2020
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