FDA 510(k) Application Details - K203746

Device Classification Name	Sleeve, Limb, Compressible   More FDA Info for this Device
510(K) Number	K203746
Device Name	Sleeve, Limb, Compressible
Applicant	Shenzhen Pango Electronic CO., LTD No.25, 1st Industry Zone, Fenghuang Road, Xikeng Village, Henggang Town, Longgang Distict Shenzhen 518115 CN Other 510(k) Applications for this Company
Contact	Guojun Zeng 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	12/22/2020
Decision Date	11/10/2021
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