FDA 510(k) Application Details - K193563

Device Classification Name	Scalpel, Ultrasonic, Reprocessed   More FDA Info for this Device
510(K) Number	K193563
Device Name	Scalpel, Ultrasonic, Reprocessed
Applicant	Surgical Instrument Service and Savings Inc (dba Medline ReN 1500 NE Hemlock Ave Redmond, OR 97756 US Other 510(k) Applications for this Company
Contact	Gail Gassner Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	NLQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/23/2019
Decision Date	08/19/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review