Cleared Traditional

KRUPIN EYE VALVE W/SCLERAL BUCKLE

K885125 · Hood Laboratories · Ophthalmic
Jan 1989
Decision
43d
Days
Class 2
Risk

About This 510(k) Submission

K885125 is an FDA 510(k) clearance for the KRUPIN EYE VALVE W/SCLERAL BUCKLE, a Implant, Eye Valve (Class II — Special Controls, product code KYF), submitted by Hood Laboratories (Pembroke, US). The FDA issued a Cleared decision on January 24, 1989, 43 days after receiving the submission on December 12, 1988. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.3920.

Submission Details

510(k) Number K885125 FDA.gov
FDA Decision Cleared SESE
Date Received December 12, 1988
Decision Date January 24, 1989
Days to Decision 43 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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