FDA 510(k) Application Details - K241415

Device Classification Name	More FDA Info for this Device
510(K) Number	K241415
Device Name	Orchid Safety Release ValveÖ
Applicant	Linear Health Sciences LLC 840 Research Parkway Ste 250 Oklahoma City, OK 73104 US Other 510(k) Applications for this Company
Contact	Jessica Czamanski 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	05/17/2024
Decision Date	09/06/2024
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