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FDA 510(k) Application Details - K161358
Device Classification Name
Apparatus, Suction, Ward Use, Portable, Ac-Powered
More FDA Info for this Device
510(K) Number
K161358
Device Name
Apparatus, Suction, Ward Use, Portable, Ac-Powered
Applicant
SURGICAL INSTRUMENT SERVICE AND SAVINGS INC
2747 SW 6TH ST.
REDMOND, OR 97756 US
Other 510(k) Applications for this Company
Contact
BRANDI J. PANTELEON
Other 510(k) Applications for this Contact
Regulation Number
878.4780
More FDA Info for this Regulation Number
Classification Product Code
JCX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/16/2016
Decision Date
08/03/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
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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