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FDA 510(k) Application Details - K150524
Device Classification Name
Scalpel, Ultrasonic, Reprocessed
More FDA Info for this Device
510(K) Number
K150524
Device Name
Scalpel, Ultrasonic, Reprocessed
Applicant
Surgical Instrument Services and Savings, Inc
(dba Medline ReNewal)
2747 SW 6th sT.
Redmond, OR 97756 US
Other 510(k) Applications for this Company
Contact
Richard D Wynkoop
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
03/02/2015
Decision Date
12/16/2015
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
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