FDA.reportPublic FDA data

510(k) K831898

Device
SCOLIMETER
Applicant
DR. MICHEAL A. SABIA
510(k) number
K831898
Product code
KTZ  
Decision
Substantially Equivalent (SESE)
Decision date
1983-07-19
Date received
1983-06-14
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
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#

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