Cleared Traditional

AOD4000 DISPOSABLE PAK

K931357 · American Optical Corp. · Ophthalmic
Jan 1994
Decision
314d
Days
Class 2
Risk

About This 510(k) Submission

K931357 is an FDA 510(k) clearance for the AOD4000 DISPOSABLE PAK, a Unit, Phacofragmentation (Class II — Special Controls, product code HQC), submitted by American Optical Corp. (Irvine, US). The FDA issued a Cleared decision on January 25, 1994, 314 days after receiving the submission on March 17, 1993. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number K931357 FDA.gov
FDA Decision Cleared SESE
Date Received March 17, 1993
Decision Date January 25, 1994
Days to Decision 314 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HQC — Unit, Phacofragmentation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4670

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