Cleared Traditional

MOLTENO VALVE SETON

K875099 · Staar Surgical Co. · Ophthalmic
Mar 1988
Decision
111d
Days
Class 2
Risk

About This 510(k) Submission

K875099 is an FDA 510(k) clearance for the MOLTENO VALVE SETON, a Implant, Eye Valve (Class II — Special Controls, product code KYF), submitted by Staar Surgical Co. (Monrovia, US). The FDA issued a Cleared decision on March 30, 1988, 111 days after receiving the submission on December 10, 1987. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.3920.

Submission Details

510(k) Number K875099 FDA.gov
FDA Decision Cleared SESE
Date Received December 10, 1987
Decision Date March 30, 1988
Days to Decision 111 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code KYF — Implant, Eye Valve
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.3920

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