Cleared Traditional

NK MEDICAL MICROMETER, MODEL MC001

K921266 · Nk Biotechnical Engineering Co. · Orthopedic
Jul 1992
Decision
120d
Days
Class 1
Risk

About This 510(k) Submission

K921266 is an FDA 510(k) clearance for the NK MEDICAL MICROMETER, MODEL MC001, a Caliper (Class I — General Controls, product code KTZ), submitted by Nk Biotechnical Engineering Co. (Minneapolis, US). The FDA issued a Cleared decision on July 14, 1992, 120 days after receiving the submission on March 16, 1992. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.4150.

Submission Details

510(k) Number K921266 FDA.gov
FDA Decision Cleared SESE
Date Received March 16, 1992
Decision Date July 14, 1992
Days to Decision 120 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement

Device Classification

Product Code KTZ — Caliper
Device Class Class I — General Controls
CFR Regulation 21 CFR 888.4150