Cleared Traditional

DISP. MICROSURGICAL KNIVES

K821737 · Coburn Optical Ind., Inc. · General & Plastic Surgery
Jul 1982
Decision
18d
Days
Class 1
Risk

About This 510(k) Submission

K821737 is an FDA 510(k) clearance for the DISP. MICROSURGICAL KNIVES, a Blade, Scalpel (Class I — General Controls, product code GES), submitted by Coburn Optical Ind., Inc. (Mchenry, US). The FDA issued a Cleared decision on July 2, 1982, 18 days after receiving the submission on June 14, 1982. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K821737 FDA.gov
FDA Decision Cleared SESE
Date Received June 14, 1982
Decision Date July 02, 1982
Days to Decision 18 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code GES — Blade, Scalpel
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800

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