Cleared Traditional

FAULKNER FORCEPS

K864071 · Staar Surgical Co. · Ophthalmic
Nov 1986
Decision
24d
Days
Class 1
Risk

About This 510(k) Submission

K864071 is an FDA 510(k) clearance for the FAULKNER FORCEPS, a Forceps, Ophthalmic (Class I — General Controls, product code HNR), submitted by Staar Surgical Co. (Monrovia, US). The FDA issued a Cleared decision on November 13, 1986, 24 days after receiving the submission on October 20, 1986. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4350.

Submission Details

510(k) Number K864071 FDA.gov
FDA Decision Cleared SESE
Date Received October 20, 1986
Decision Date November 13, 1986
Days to Decision 24 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

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

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