Cleared Traditional

MARCO H AND TS-1 INSTRUMENT TABLES

K930447 · Marco Ophthalmic, Inc. · Ophthalmic
Jul 1993
Decision
161d
Days
Class 1
Risk

About This 510(k) Submission

K930447 is an FDA 510(k) clearance for the MARCO H AND TS-1 INSTRUMENT TABLES, a Table, Instrument, Powered, Ophthalmic (Class I — General Controls, product code HRJ), submitted by Marco Ophthalmic, Inc. (Jacksonville, US). The FDA issued a Cleared decision on July 6, 1993, 161 days after receiving the submission on January 26, 1993. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4855.

Submission Details

510(k) Number K930447 FDA.gov
FDA Decision Cleared SESE
Date Received January 26, 1993
Decision Date July 06, 1993
Days to Decision 161 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code HRJ — Table, Instrument, Powered, Ophthalmic
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4855