Cleared Traditional

HYSTERECTOMY FORCEPS

K926531 · Thomasville Medical Assoc. · Obstetrics & Gynecology
Feb 1994
Decision
422d
Days
Class 2
Risk

About This 510(k) Submission

K926531 is an FDA 510(k) clearance for the HYSTERECTOMY FORCEPS, a Forceps, Surgical, Gynecological (Class II — Special Controls, product code HCZ), submitted by Thomasville Medical Assoc. (Alpharetta, US). The FDA issued a Cleared decision on February 25, 1994, 422 days after receiving the submission on December 30, 1992. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number K926531 FDA.gov
FDA Decision Cleared SESE
Date Received December 30, 1992
Decision Date February 25, 1994
Days to Decision 422 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement

Device Classification

Product Code HCZ — Forceps, Surgical, Gynecological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.4530

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