Cleared Abbreviated

PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE

K141638 · Propper Manufacturing Co., Inc. · Ophthalmic

Sep 2014

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K141638 is an FDA 510(k) clearance for the PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE, a Ophthalmoscope, Ac-powered (Class II — Special Controls, product code HLI), submitted by Propper Manufacturing Co., Inc. (Long Island, US). The FDA issued a Cleared decision on September 17, 2014, 90 days after receiving the submission on June 19, 2014. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number	K141638 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 19, 2014
Decision Date	September 17, 2014
Days to Decision	90 days
Submission Type	Abbreviated
Review Panel	Ophthalmic (OP)
Summary	Summary PDF