FDA 510(k) Application Details - K220761

Device Classification Name	Sleeve, Limb, Compressible   More FDA Info for this Device
510(K) Number	K220761
Device Name	Sleeve, Limb, Compressible
Applicant	Ortho8, Inc. 2217 Plaza Drive Rocklin, CA 95765 US Other 510(k) Applications for this Company
Contact	Jeff Culhane 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	03/15/2022
Decision Date	06/03/2022
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