510(k) K921266

Device
NK MEDICAL MICROMETER, MODEL MC001
Applicant
NK BIOTECHNICAL ENGINEERING CO.
510(k) number
K921266
Product code
KTZ  
Decision
Substantially Equivalent (SESE)
Decision date
1992-07-14
Date received
1992-03-16
Regulation
888.4150
Classification name
Caliper
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
KAREN GOTGREDSON
Address
P.O. Box 26335 Minneapolis MN US 55426 55426

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
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
K800363PARKE-DAVIS TOTAL KNEE PROSTHESISWarner-Lambert Co.1980-03-10
K760521TAPE MEASUREMcgaw Laboratories1976-11-12

Legacy Summary#

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FDA Review#

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