FDA 510(k) Application Details - K181936

Device Classification Name	Injector And Syringe, Angiographic   More FDA Info for this Device
510(K) Number	K181936
Device Name	Injector And Syringe, Angiographic
Applicant	Osprey Medical, Inc. 5600 Rowland Rd, Suite 250 Minnetonka, MN 55343 US Other 510(k) Applications for this Company
Contact	Vic Fabano Other 510(k) Applications for this Contact
Regulation Number	870.1650   More FDA Info for this Regulation Number
Classification Product Code	DXT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/19/2018
Decision Date	10/25/2018
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
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