Cleared Traditional

OPHTHALMIC KNIFE & FORCEPS

K864266 · Western Medical Products, Inc. · Ophthalmic
Nov 1986
Decision
30d
Days
Class 1
Risk

About This 510(k) Submission

K864266 is an FDA 510(k) clearance for the OPHTHALMIC KNIFE & FORCEPS, a Forceps, Ophthalmic (Class I — General Controls, product code HNR), submitted by Western Medical Products, Inc. (Sherman Oaks, US). The FDA issued a Cleared decision on November 28, 1986, 30 days after receiving the submission on October 29, 1986. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4350.

Submission Details

510(k) Number K864266 FDA.gov
FDA Decision Cleared SESE
Date Received October 29, 1986
Decision Date November 28, 1986
Days to Decision 30 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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