Cleared Traditional

LN 100 BREAST MARKER

K872319 · Instrumentation Industries, Inc. · General & Plastic Surgery
Aug 1987
Decision
55d
Days
Class 1
Risk

About This 510(k) Submission

K872319 is an FDA 510(k) clearance for the LN 100 BREAST MARKER, a Tape, Measuring, Rulers And Calipers (Class I — General Controls, product code FTY), submitted by Instrumentation Industries, Inc. (Bethel Park, US). The FDA issued a Cleared decision on August 11, 1987, 55 days after receiving the submission on June 17, 1987. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K872319 FDA.gov
FDA Decision Cleared SESE
Date Received June 17, 1987
Decision Date August 11, 1987
Days to Decision 55 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

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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