Cleared Traditional

K801075 - STRAITH CHISEL FORCEPS
(FDA 510(k) Clearance)

K801075 · Surgical Technology Laboratories, Inc. · General & Plastic Surgery
May 1980
Decision
14d
Days
Class 1
Risk

K801075 is an FDA 510(k) clearance for the STRAITH CHISEL FORCEPS, a Forceps, General & Plastic Surgery (Class I — General Controls, product code GEN), submitted by Surgical Technology Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 20, 1980, 14 days after receiving the submission on May 6, 1980. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K801075 FDA.gov
FDA Decision Cleared SESE
Date Received May 06, 1980
Decision Date May 20, 1980
Days to Decision 14 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