Cleared Traditional

ACRYPAK FOLDER

K965185 · Alcon Laboratories · Ophthalmic
Mar 1997
Decision
97d
Days
Class 1
Risk

About This 510(k) Submission

K965185 is an FDA 510(k) clearance for the ACRYPAK FOLDER, a Lens, Guide, Intraocular (Class I — General Controls, product code KYB), submitted by Alcon Laboratories (Fort Worth, US). The FDA issued a Cleared decision on March 31, 1997, 97 days after receiving the submission on December 24, 1996. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4300.

Submission Details

510(k) Number K965185 FDA.gov
FDA Decision Cleared SESE
Date Received December 24, 1996
Decision Date March 31, 1997
Days to Decision 97 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

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

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