Cleared Traditional

K873099 - MANUAL OPHTHALMIC SURGICAL INSTRUMENTS
(FDA 510(k) Clearance)

Sep 1987
Decision
28d
Days
Class 1
Risk

K873099 is an FDA 510(k) clearance for the MANUAL OPHTHALMIC SURGICAL INSTRUMENTS. This device is classified as a Scissors, Ophthalmic (Class I - General Controls, product code HNF).

Submitted by Alcon Laboratories (Fort Worth, US). The FDA issued a Cleared decision on September 4, 1987, 28 days after receiving the submission on August 7, 1987.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4350.

Submission Details

510(k) Number K873099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1987
Decision Date September 04, 1987
Days to Decision 28 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary

Device Classification

Product Code HNF — Scissors, Ophthalmic
Device Class Class I - General Controls
CFR Regulation 21 CFR 886.4350

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