Cleared Traditional

BOZEMAN UTERINE FORCEPS, STRAIGHT, 10+410 0R 420

K852721 · The Huxley Instrument Corp. · Obstetrics & Gynecology
Sep 1985
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K852721 is an FDA 510(k) clearance for the BOZEMAN UTERINE FORCEPS, STRAIGHT, 10+410 0R 420, a Forceps, Surgical, Gynecological (Class II — Special Controls, product code HCZ), submitted by The Huxley Instrument Corp. (Penn Yan, US). The FDA issued a Cleared decision on September 6, 1985, 72 days after receiving the submission on June 26, 1985. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number K852721 FDA.gov
FDA Decision Cleared SESE
Date Received June 26, 1985
Decision Date September 06, 1985
Days to Decision 72 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary —

Device Classification

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

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