Cleared Traditional

OLYMPIC AUTO-LENGTH

K934930 · Olympic Medical Corp. · General & Plastic Surgery
Dec 1993
Decision
76d
Days
Class 1
Risk

About This 510(k) Submission

K934930 is an FDA 510(k) clearance for the OLYMPIC AUTO-LENGTH, a Tape, Measuring, Rulers And Calipers (Class I — General Controls, product code FTY), submitted by Olympic Medical Corp. (Seattle, US). The FDA issued a Cleared decision on December 29, 1993, 76 days after receiving the submission on October 14, 1993. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K934930 FDA.gov
FDA Decision Cleared SESE
Date Received October 14, 1993
Decision Date December 29, 1993
Days to Decision 76 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code FTY — Tape, Measuring, Rulers And Calipers
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800

Similar Devices — FTY Tape, Measuring, Rulers And Calipers

All 22
Noxilizer Surgical Ruler
K160501 · Noxilizer, Inc. · May 2016
DISPOSABLE WOUND MEASURE GUIDE, PLASTIC, PROTECTOR, WOUND, PLASTIC
K951064 · S-E Sales & Distribution, Inc. · May 1995
OLYMPIC INFA-LENGTH
K932112 · Olympic Medical Corp. · Jul 1993
STRYKER PRESSURE MONITOR SYSTEM
K883485 · Stryker Corp. · Sep 1988
PEDIATRIC AIRWAY MEASUREMENT SYSTEM & P.A.M.S.
K880441 · Plane Iii, Inc. · Feb 1988
TUMORIMETER
K874352 · Cancer Technologies, Inc. · Nov 1987