Cleared Traditional

MAZZOCCO/FRENCHIK FOLDER

K860148 · Staar Surgical Co. · Ophthalmic
Mar 1986
Decision
65d
Days
Class 1
Risk

About This 510(k) Submission

K860148 is an FDA 510(k) clearance for the MAZZOCCO/FRENCHIK FOLDER, a Lens, Guide, Intraocular (Class I — General Controls, product code KYB), submitted by Staar Surgical Co. (Monrovia, US). The FDA issued a Cleared decision on March 21, 1986, 65 days after receiving the submission on January 15, 1986. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4300.

Submission Details

510(k) Number K860148 FDA.gov
FDA Decision Cleared SESE
Date Received January 15, 1986
Decision Date March 21, 1986
Days to Decision 65 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code KYB — Lens, Guide, Intraocular
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4300

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