Cleared Traditional

K771624 - COPE LUNG FORCEPS #305-218
(FDA 510(k) Clearance)

K771624 · J. Jamner Surgical Instruments, Inc. · General & Plastic Surgery
Sep 1977
Decision
12d
Days
Class 1
Risk

K771624 is an FDA 510(k) clearance for the COPE LUNG FORCEPS #305-218. This device is classified as a Forceps, General & Plastic Surgery (Class I — General Controls, product code GEN).

Submitted by J. Jamner Surgical Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 6, 1977, 12 days after receiving the submission on August 25, 1977.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K771624 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1977
Decision Date September 06, 1977
Days to Decision 12 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

Product Code GEN — Forceps, General & Plastic Surgery
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800