FDA 510(k) Application Details - K251101

Device Classification Name	Pump, Portable, Aspiration (Manual Or Powered)   More FDA Info for this Device
510(K) Number	K251101
Device Name	Pump, Portable, Aspiration (Manual Or Powered)
Applicant	CRO, LLC 516 E Spruce St. Missoula, MT 59802 US Other 510(k) Applications for this Company
Contact	Jeffrey Boardman Other 510(k) Applications for this Contact
Regulation Number	878.4780   More FDA Info for this Regulation Number
Classification Product Code	BTA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/11/2025
Decision Date	04/26/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review