Cleared Traditional

K760521: TAPE MEASURE

K760521 · Mcgaw Laboratories · Orthopedic
Nov 1976
Decision
78d
Days
Class 1
Risk

K760521 is an FDA 510(k) clearance for the TAPE MEASURE, a Caliper (Class I — General Controls, product code KTZ), submitted by Mcgaw Laboratories (Walker, US). The FDA issued a Cleared decision on November 12, 1976, 78 days after receiving the submission on August 26, 1976. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.4150.

Submission Details

510(k) Number K760521 FDA.gov
FDA Decision Cleared SESE
Date Received August 26, 1976
Decision Date November 12, 1976
Days to Decision 78 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary

Device Classification

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