Cleared Traditional

PHACO-BAC STOP KIT

K850900 · Staar Surgical Co. · Ophthalmic
Mar 1985
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K850900 is an FDA 510(k) clearance for the PHACO-BAC STOP 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 March 29, 1985, 25 days after receiving the submission on March 4, 1985. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number K850900 FDA.gov
FDA Decision Cleared SESE
Date Received March 04, 1985
Decision Date March 29, 1985
Days to Decision 25 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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