FDA 510(k) Application Details - K212287

Device Classification Name	Sleeve, Limb, Compressible   More FDA Info for this Device
510(K) Number	K212287
Device Name	Sleeve, Limb, Compressible
Applicant	Koya Medical, Inc. 2461 Peralta St. Oakland, CA 94607 US Other 510(k) Applications for this Company
Contact	Jarren Baldwin 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	07/21/2021
Decision Date	09/21/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review