Cleared Traditional

MARCO SURGISCOPE OPERATION MICROSCOPES

K930439 · Marco Ophthalmic, Inc. · General & Plastic Surgery
Jul 1993
Decision
177d
Days
Class 1
Risk

About This 510(k) Submission

K930439 is an FDA 510(k) clearance for the MARCO SURGISCOPE OPERATION MICROSCOPES, a Microscope, Operating & Accessories, Ac-powered, Ophthalmic (Class I — General Controls, product code HRM), submitted by Marco Ophthalmic, Inc. (Jacksonville, US). The FDA issued a Cleared decision on July 22, 1993, 177 days after receiving the submission on January 26, 1993. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4700.

Submission Details

510(k) Number K930439 FDA.gov
FDA Decision Cleared SESE
Date Received January 26, 1993
Decision Date July 22, 1993
Days to Decision 177 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code HRM — Microscope, Operating & Accessories, Ac-powered, Ophthalmic
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4700

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