Cleared Traditional

DEKNATEL (R) TREPHINE

K862524 · Deknatel, Inc. · Ophthalmic
Aug 1986
Decision
40d
Days
Class 1
Risk

About This 510(k) Submission

K862524 is an FDA 510(k) clearance for the DEKNATEL (R) TREPHINE, a Trephine, Manual, Ophthalmic (Class I — General Controls, product code HRH), submitted by Deknatel, Inc. (Lake Success, US). The FDA issued a Cleared decision on August 11, 1986, 40 days after receiving the submission on July 2, 1986. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4350.

Submission Details

510(k) Number K862524 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 1986
Decision Date August 11, 1986
Days to Decision 40 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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