Cleared Traditional

K932385 - SUTURE REMOVING FORCEPS (FDA 510(k) Clearance)

Aug 1993
Decision
81d
Days
Class 1
Risk

K932385 is an FDA 510(k) clearance for the SUTURE REMOVING FORCEPS. This device is classified as a Forceps, General & Plastic Surgery (Class I - General Controls, product code GEN).

Submitted by Rocket of London, Ltd. (Tyne & Wear, GB). The FDA issued a Cleared decision on August 6, 1993, 81 days after receiving the submission on May 17, 1993.

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

Submission Details

510(k) Number K932385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1993
Decision Date August 06, 1993
Days to Decision 81 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

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

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