Cleared Traditional

STEPHENS DISPOSABLE FORCEPS

K022835 · Stephens Instruments · Ophthalmic
Nov 2002
Decision
66d
Days
Class 1
Risk

About This 510(k) Submission

K022835 is an FDA 510(k) clearance for the STEPHENS DISPOSABLE FORCEPS, a Forceps, Ophthalmic (Class I — General Controls, product code HNR), submitted by Stephens Instruments (Lexington, US). The FDA issued a Cleared decision on November 1, 2002, 66 days after receiving the submission on August 27, 2002. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4350.

Submission Details

510(k) Number K022835 FDA.gov
FDA Decision Cleared SESE
Date Received August 27, 2002
Decision Date November 01, 2002
Days to Decision 66 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HNR — Forceps, Ophthalmic
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4350

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