Cleared Traditional

SURGE-FREE ASPIRATION ADAPTER

K020734 · Staar Surgical Co. · Ophthalmic
May 2002
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K020734 is an FDA 510(k) clearance for the SURGE-FREE ASPIRATION ADAPTER, a Unit, Phacofragmentation (Class II — Special Controls, product code HQC), submitted by Staar Surgical Co. (Monrovia, US). The FDA issued a Cleared decision on May 16, 2002, 71 days after receiving the submission on March 6, 2002. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number K020734 FDA.gov
FDA Decision Cleared SESE
Date Received March 06, 2002
Decision Date May 16, 2002
Days to Decision 71 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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