Cleared Traditional

PEARL PACKING FORCEPS

K941528 · Cook Urological, Inc. · Obstetrics & Gynecology
May 1994
Decision
43d
Days
Class 2
Risk

About This 510(k) Submission

K941528 is an FDA 510(k) clearance for the PEARL PACKING FORCEPS, a Forceps, Surgical, Gynecological (Class II — Special Controls, product code HCZ), submitted by Cook Urological, Inc. (Spencer, US). The FDA issued a Cleared decision on May 12, 1994, 43 days after receiving the submission on March 30, 1994. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number K941528 FDA.gov
FDA Decision Cleared SESE
Date Received March 30, 1994
Decision Date May 12, 1994
Days to Decision 43 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

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

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