Cleared Traditional

STORZ DP4210 VENTURI ECONOMY ANTERIOR PACK AND DP5000 ASC DAYPACK

K980100 · Storz Instrument Co. · Ophthalmic
Jun 1998
Decision
140d
Days
Class 2
Risk

About This 510(k) Submission

K980100 is an FDA 510(k) clearance for the STORZ DP4210 VENTURI ECONOMY ANTERIOR PACK AND DP5000 ASC DAYPACK, a Tubing, Replacement, Phacofragmentation Unit (Class II — Special Controls, product code MSR), submitted by Storz Instrument Co. (St. Louis, US). The FDA issued a Cleared decision on June 1, 1998, 140 days after receiving the submission on January 12, 1998. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4150.

Submission Details

510(k) Number K980100 FDA.gov
FDA Decision Cleared SESE
Date Received January 12, 1998
Decision Date June 01, 1998
Days to Decision 140 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code MSR — Tubing, Replacement, Phacofragmentation Unit
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4150