FDA 510(k) Application Details - K212064

Device Classification Name	More FDA Info for this Device
510(K) Number	K212064
Device Name	Orchid Safety Release Valve(TM)
Applicant	Linear Health Sciences, LLC 5333 Wisteria Drive Oklahoma City, OK 73142 US Other 510(k) Applications for this Company
Contact	Daniel Clark Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QOI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/02/2021
Decision Date	05/03/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review