Cleared Traditional

STORZ MILLENNIUM VISCOUS FLUID SYSTEM

K972664 · Storz Instrument Co. · Ophthalmic
Oct 1997
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K972664 is an FDA 510(k) clearance for the STORZ MILLENNIUM VISCOUS FLUID SYSTEM, a Pump, Infusion, Ophthalmic (Class II — Special Controls, product code MRH), submitted by Storz Instrument Co. (St. Louis, US). The FDA issued a Cleared decision on October 10, 1997, 86 days after receiving the submission on July 16, 1997. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K972664 FDA.gov
FDA Decision Cleared SESE
Date Received July 16, 1997
Decision Date October 10, 1997
Days to Decision 86 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