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510(k) K924713

Device
UNIVERSAL SURGICAL INSTRUMENT HOLDER
Applicant
T. KOROS SURGICAL INSTRUMENTS CORP.
510(k) number
K924713
Product code
FWW  
Decision
Substantially Equivalent (SESE)
Decision date
1993-05-17
Date received
1992-09-18
Regulation
878.4960
Classification name
Table, Operating-room, Pneumatic
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
TIBOR KOROS
Address
610 Flinn Ave. Moorepark CA US 93021 93021

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FWW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K953961OSTEONICS INSIGHT KNEE POSITIONING & ALIGNMENT SYSTEMOsteonics Corp.1995-11-29
K935356CAPTAIN'S CHAIR ACCESSORY TO AMSCO SURGICAL TABLESAmsco American Sterilizer Co.1994-03-23
K931876FISK ARM SUPPORTVvortex International Corp.1993-09-09
K863161TABLE, OPERATING ROOM, HYDRAULICKamiya Tsusan Kaisha, Ltd.1986-09-05
K853479SKYTRON ELITE 300 SURGERY TABLESkytron, Div. the Kmw Group, Inc.1985-09-05

Legacy Summary#

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FDA Review#

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