Cleared Traditional

OPHTHALMIC TIP & BLADE SCALPELS

K874057 · Myocure, Inc. · Ophthalmic
Dec 1987
Decision
79d
Days
Class 1
Risk

About This 510(k) Submission

K874057 is an FDA 510(k) clearance for the OPHTHALMIC TIP & BLADE SCALPELS, a Knife, Ophthalmic (Class I — General Controls, product code HNN), submitted by Myocure, Inc. (Glendale, US). The FDA issued a Cleared decision on December 23, 1987, 79 days after receiving the submission on October 5, 1987. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4350.

Submission Details

510(k) Number K874057 FDA.gov
FDA Decision Cleared SESE
Date Received October 05, 1987
Decision Date December 23, 1987
Days to Decision 79 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HNN — Knife, Ophthalmic
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4350

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