FDA 510(k) Application Details - K193361

Device Classification Name	Apparatus, Autotransfusion   More FDA Info for this Device
510(K) Number	K193361
Device Name	Apparatus, Autotransfusion
Applicant	ProCell Surgical, Inc. 19 Menin Rd Toronto M6C 3J1 CA Other 510(k) Applications for this Company
Contact	Robert Krensky Other 510(k) Applications for this Contact
Regulation Number	868.5830   More FDA Info for this Regulation Number
Classification Product Code	CAC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/04/2019
Decision Date	06/01/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review