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510(k) K863161

Device
TABLE, OPERATING ROOM, HYDRAULIC
Applicant
KAMIYA TSUSAN KAISHA, LTD.
510(k) number
K863161
Product code
FWW  
Decision
Substantially Equivalent (SESE)
Decision date
1986-09-05
Date received
1986-08-18
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
Third party reviewed
No

Applicant Contact#

Contact
OSOZAWA
Address
C P O Box 1590 Tokyo, 100-91 Japan JP

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
K924713UNIVERSAL SURGICAL INSTRUMENT HOLDERT. Korossurgical Instruments Corp.1993-05-17
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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