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510(k) K851830

Device
SKYTRON ELITE 7000 MICRO-SURGERY TABLE
Applicant
SKYTRON, DIV. THE KMW GROUP, INC.
510(k) number
K851830
Product code
GDC  
Decision
Substantially Equivalent (SESE)
Decision date
1985-05-17
Date received
1985-04-26
Regulation
878.4960
Classification name
Table, Operating-room, Electrical
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
LARRY J PURCEY
Address
5000 36th St., SE Grand Rapids MI US 49512 49512

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GDC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K971390QUANTUM 3080SP SURGICAL TABLESTERIS Corporation1997-05-15
K970807MOBILE OPERATING TABLE 1132.01Stierlen-Maquet AG1997-03-14
K964273DURA-BOARD ARMBOARDAllen Medical Systems, Inc.1997-01-08
K940616SKYTRON ELITE 3500 TABLESkytron, Div. the Kmw Group, Inc.1994-06-13
K934744MIDMARK MAGNUM GENERAL SURGICAL TABLEMidmark Corp.1994-03-28
K914758MDT/SHAMPAINE MODEL 4900B SURGICAL TABLEMdt Corp., Inc.1991-12-19
K915393MDT/SHAMPAINE MODEL 4900E SURGICAL TABLEMdt Corp., Inc.1991-12-17
K883613OPER. TABLE FOR PERCUTAN. TRANS. CORONARY ANGIO.Stierlen-Maquet AG1988-09-15
K853720MOBILE OPERATING TABLE FOR ORL MICROSURGERYCarl Zeiss, Inc.1985-10-18
K853480SKYTRON ELITE 6000 & 6001 SURGICAL TABLESSkytron, Div. the Kmw Group, Inc.1985-09-12
K853535TRAUMA TABLEXre Corp.1985-09-11
K851021MAYFIELD TABLE-ELECTRICOhio Medical Instrument Co., Inc.1985-05-21
K851829SKYTRON ELITE 3100 SURGICAL TABLESkytron, Div. the Kmw Group, Inc.1985-05-17
K850168STILLE SCANDIA OPERATING TABLES RC 3000,1100Stille-Werner (Usa), Inc.1985-03-28
K843134MOBILE OPERATING TABLE HEIDELBERGS 1130Stierlen-Maquet AG1984-09-07

Legacy Summary#

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FDA Review#

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