Cleared Traditional

OLYMPIC INFA-LENGTH

K932112 · Olympic Medical Corp. · General & Plastic Surgery
Jul 1993
Decision
80d
Days
Class 1
Risk

About This 510(k) Submission

K932112 is an FDA 510(k) clearance for the OLYMPIC INFA-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 July 22, 1993, 80 days after receiving the submission on May 3, 1993. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K932112 FDA.gov
FDA Decision Cleared SESE
Date Received May 03, 1993
Decision Date July 22, 1993
Days to Decision 80 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

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

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