Cleared Traditional

SURGIN KIT

K980849 · Surgin Surgical Instrumentation, Inc. · Ophthalmic
Jul 1998
Decision
154d
Days
Class 2
Risk

About This 510(k) Submission

K980849 is an FDA 510(k) clearance for the SURGIN KIT, a Tubing, Replacement, Phacofragmentation Unit (Class II — Special Controls, product code MSR), submitted by Surgin Surgical Instrumentation, Inc. (Tustin, US). The FDA issued a Cleared decision on July 9, 1998, 154 days after receiving the submission on February 5, 1998. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4150.

Submission Details

510(k) Number K980849 FDA.gov
FDA Decision Cleared SESE
Date Received February 05, 1998
Decision Date July 09, 1998
Days to Decision 154 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

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