Cleared Traditional

K930441 - MARCO STANDARD LENSMETERS 101,201
(FDA 510(k) Clearance)

K930441 · Marco Ophthalmic, Inc. · Ophthalmic

Jul 1993

Decision

161d

Days

Class 1

Risk

K930441 is an FDA 510(k) clearance for the MARCO STANDARD LENSMETERS 101,201, a Instrument, Measuring, Lens, Ac-powered (Class I — General Controls, product code HLM), 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 886.1425.

Submission Details

510(k) Number	K930441 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