FDA 510(k) Application Details - K173012

Device Classification Name	Sleeve, Limb, Compressible   More FDA Info for this Device
510(K) Number	K173012
Device Name	Sleeve, Limb, Compressible
Applicant	Pegasus Medical Supply, Inc. No. 27-1, Ln. 473, Sec. 2, Hezun N. Rd., Zhongli City Taoyuan County 32060 TW Other 510(k) Applications for this Company
Contact	Pao-Ming Shih 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	09/27/2017
Decision Date	05/10/2018
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