Cleared Traditional

SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003

K000420 · Retinalabs.Com · Ophthalmic
May 2000
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K000420 is an FDA 510(k) clearance for the SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003, a Pump, Infusion, Ophthalmic (Class II — Special Controls, product code MRH), submitted by Retinalabs.Com (Atlanta, US). The FDA issued a Cleared decision on May 8, 2000, 90 days after receiving the submission on February 8, 2000. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K000420 FDA.gov
FDA Decision Cleared SESE
Date Received February 08, 2000
Decision Date May 08, 2000
Days to Decision 90 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code MRH — Pump, Infusion, Ophthalmic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725