Cleared Traditional

TUBING EXTENSION SET

K993361 · Hurricane Medical · Ophthalmic
Jan 2000
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K993361 is an FDA 510(k) clearance for the TUBING EXTENSION SET, a Tubing, Replacement, Phacofragmentation Unit (Class II — Special Controls, product code MSR), submitted by Hurricane Medical (Bradenton, US). The FDA issued a Cleared decision on January 4, 2000, 90 days after receiving the submission on October 6, 1999. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4150.

Submission Details

510(k) Number K993361 FDA.gov
FDA Decision Cleared SESE
Date Received October 06, 1999
Decision Date January 04, 2000
Days to Decision 90 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