Cleared Traditional

PHACO-BAC STOP FILTER KIT

K852208 · Staar Surgical Co. · Ophthalmic
Aug 1985
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K852208 is an FDA 510(k) clearance for the PHACO-BAC STOP FILTER KIT, a Unit, Phacofragmentation (Class II — Special Controls, product code HQC), submitted by Staar Surgical Co. (Monrovia, US). The FDA issued a Cleared decision on August 20, 1985, 91 days after receiving the submission on May 21, 1985. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number K852208 FDA.gov
FDA Decision Cleared SESE
Date Received May 21, 1985
Decision Date August 20, 1985
Days to Decision 91 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

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

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