FDA 510(k) Application Details - K210328

Device Classification Name	Trocar   More FDA Info for this Device
510(K) Number	K210328
Device Name	Trocar
Applicant	Pressure Products Medical Device Manufacturing LLC 1 School Street Morton, PA 19070 US Other 510(k) Applications for this Company
Contact	Andrew Amour Other 510(k) Applications for this Contact
Regulation Number	870.1390   More FDA Info for this Regulation Number
Classification Product Code	DRC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/04/2021
Decision Date	03/05/2021
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