Cleared Traditional

CORNEAL TRANSPLANT TREPHINE DISPOSABLE BLADE

K861825 · Storz Instrument Co. · Ophthalmic
Jun 1986
Decision
28d
Days
Class 1
Risk

About This 510(k) Submission

K861825 is an FDA 510(k) clearance for the CORNEAL TRANSPLANT TREPHINE DISPOSABLE BLADE, a Trephine, Manual, Ophthalmic (Class I — General Controls, product code HRH), submitted by Storz Instrument Co. (St. Louis, US). The FDA issued a Cleared decision on June 9, 1986, 28 days after receiving the submission on May 12, 1986. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4350.

Submission Details

510(k) Number K861825 FDA.gov
FDA Decision Cleared SESE
Date Received May 12, 1986
Decision Date June 09, 1986
Days to Decision 28 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HRH — Trephine, Manual, Ophthalmic
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4350

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