A Caliper

FDA 510(k) K820659 · Twin City Surgical, Inc.

Substantially Equivalent

510(k) numberK820659

Submission

Device name
A Caliper
Applicant
Twin City Surgical, Inc.
Mchenry, IL, US
Received
March 10, 1982
Decision date
March 19, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KTZ – Caliper
Device class
Class I (low risk)
Regulation
21 CFR 888.4150
Specialty
Orthopedic

Other 510(k)s with product code KTZ

510(k)DeviceApplicantDecision
K921266NK Medical Micrometer, Model MC001KTZ · Traditional Nk Biotechnical Engineering Co.07/14/1992SE
K841687Skyndex Electronic Body Fat CalculaKTZ · Traditional Caldwell, Justiss & Co., Inc.06/28/1984SE
K831898ScolimeterKTZ · Traditional Dr. Micheal A. Sabia07/19/1983SE
K810116Isorobic Skinfold CaliperKTZ · Traditional Fitness Motivation Institute of America02/04/1981SE
K800363Parke-Davis Total Knee ProsthesisKTZ · Traditional Warner-Lambert Co.03/10/1980SE
K760521Tape MeasureKTZ · Traditional Mcgaw Laboratories11/12/1976SE

More from Mcgaw Laboratories

510(k)DeviceDecision
K870767The (Crom) TesterKQW · Traditional 03/17/1987SE
K861632Sims ChairIKK · Traditional 05/27/1986SE
K830585Anvil RetractorGAD · Traditional 05/27/1983SE
K820660A Hook DriverKWP · Traditional 03/19/1982SE
K813067Spinal WrenchHXC · Traditional 11/24/1981SE

Questions and answers

When was A Caliper cleared by the FDA?

A Caliper (K820659) received a 510(k) decision of Substantially Equivalent on March 19, 1982, 9 days after the submission was received.

What is the product code of K820659?

The FDA product code is KTZ – Caliper, a Class I (low risk) device regulated under 21 CFR 888.4150.