FDA.reportPublic FDA data

510(k) K833509

Device
Chemonucleolysis Table
Applicant
STRYKER CORP.
510(k) number
K833509
Product code
FWY
Decision
Substantially Equivalent (SESE)
Decision date
1983-11-28
Date received
1983-10-11
Regulation
878.4950
Classification name
Table, Operating-Room, Non-Electrical
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FWY#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K883457ASST-3000 SPINAL SURGERY TABLEOrthopedic Systems, Inc.1988-08-26
K873478SKYTRON MODEL 130 SURGICAL TABLESkytron, Div. the Kmw Group, Inc.1987-09-24
K800118CHICK SURGICAL TABLEWarner-Lambert Co.1980-02-05