FDA.reportPublic FDA data

510(k) K853479

Device
SKYTRON ELITE 300 SURGERY TABLE
Applicant
SKYTRON, DIV. THE KMW GROUP, INC.
510(k) number
K853479
Product code
FWW  
Decision
Substantially Equivalent (SESE)
Decision date
1985-09-05
Date received
1985-08-20
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
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 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
K863161TABLE, OPERATING ROOM, HYDRAULICKamiya Tsusan Kaisha, Ltd.1986-09-05

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases