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510(k) K800363

Device
PARKE-DAVIS TOTAL KNEE PROSTHESIS
Applicant
WARNER-LAMBERT CO.
510(k) number
K800363
Product code
KTZ  
Decision
Substantially Equivalent (SESE)
Decision date
1980-03-10
Date received
1980-02-20
Regulation
888.4150
Classification name
Caliper
Medical specialty
Orthopedic
Review panel
Orthopedic
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 KTZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K921266NK MEDICAL MICROMETER, MODEL MC001Nk Biotechnical Engineering Co.1992-07-14
K841687SKYNDEX ELECTRONIC BODY FAT CALCULACaldwell, Justiss & Co., Inc.1984-06-28
K831898SCOLIMETERDr. Micheal A. Sabia1983-07-19
K820659A CALIPERTwin City Surgical, Inc.1982-03-19
K810116ISOROBIC SKINFOLD CALIPERFitness Motivation Institute of America1981-02-04
K760521TAPE MEASUREMcgaw Laboratories1976-11-12

Legacy Summary#

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FDA Review#

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