FDA 510(k) Application Details - K190423

Device Classification Name	Sleeve, Limb, Compressible   More FDA Info for this Device
510(K) Number	K190423
Device Name	Sleeve, Limb, Compressible
Applicant	Devon Medical Products (Jiangsu) Ltd East Half of 1-2F, Appt D2, 1, Qingfeng Road Nantong 226017 CN Other 510(k) Applications for this Company
Contact	Neil Cheng 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	02/22/2019
Decision Date	03/19/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review