Cleared Traditional

K851768 - 13-550,13-560 WESCOTT SCOSSORS (EYE)
(FDA 510(k) Clearance)

Jun 1985
Decision
56d
Days
Class 1
Risk

K851768 is an FDA 510(k) clearance for the 13-550,13-560 WESCOTT SCOSSORS (EYE). This device is classified as a Scissors, Ophthalmic (Class I - General Controls, product code HNF).

Submitted by Artiberia (San Antonio, US). The FDA issued a Cleared decision on June 20, 1985, 56 days after receiving the submission on April 25, 1985.

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

Submission Details

510(k) Number K851768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1985
Decision Date June 20, 1985
Days to Decision 56 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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