FDA 510(k) Application Details - K242820

Device Classification Name	More FDA Info for this Device
510(K) Number	K242820
Device Name	Puritan PurSafe Plus Collection and Transport System
Applicant	Puritan Medical Products LLC 31 School Street PO Box 149 Gulford, ME 04443-0149 US Other 510(k) Applications for this Company
Contact	Mehdi Karamchi Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QBD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/18/2024
Decision Date	05/27/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review