Cleared Traditional

MARCO STANDARD RADIUSGAUGES

K930437 · Marco Ophthalmic, Inc. · Ophthalmic

Aug 1993

Decision

195d

Days

Class 1

Risk

About This 510(k) Submission

K930437 is an FDA 510(k) clearance for the MARCO STANDARD RADIUSGAUGES, a Device, Measuring, Lens Radius, Ophthalmic (Class I — General Controls, product code HLF), submitted by Marco Ophthalmic, Inc. (Jacksonville, US). The FDA issued a Cleared decision on August 9, 1993, 195 days after receiving the submission on January 26, 1993. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1430.

Submission Details

510(k) Number	K930437 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 26, 1993
Decision Date	August 09, 1993
Days to Decision	195 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Statement