FDA 510(k) Application Details - K241096

Device Classification Name	Sleeve, Limb, Compressible   More FDA Info for this Device
510(K) Number	K241096
Device Name	Sleeve, Limb, Compressible
Applicant	Suzhou Minhua Medical Apparatus Supplies Co., Ltd You Yi Industrial Park, Songlin Town, Wujiang Suzhou 215222 CN Other 510(k) Applications for this Company
Contact	Alex Wang 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	04/22/2024
Decision Date	01/15/2025
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