Cleared Traditional

BACSTOP FILTER IRRIGATION SUPPLY KIT

K860544 · Staar Surgical Co. · Ophthalmic
Apr 1986
Decision
50d
Days
Class 1
Risk

About This 510(k) Submission

K860544 is an FDA 510(k) clearance for the BACSTOP FILTER IRRIGATION SUPPLY KIT, a Device, Irrigation, Ocular Surgery (Class I — General Controls, product code KYG), submitted by Staar Surgical Co. (Monrovia, US). The FDA issued a Cleared decision on April 4, 1986, 50 days after receiving the submission on February 13, 1986. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4360.

Submission Details

510(k) Number K860544 FDA.gov
FDA Decision Cleared SESE
Date Received February 13, 1986
Decision Date April 04, 1986
Days to Decision 50 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code KYG — Device, Irrigation, Ocular Surgery
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4360

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