Cleared Traditional

K151575 - Dynarex Eye Cups
(FDA 510(k) Clearance)

K151575 · Dynarex Corporation · Ophthalmic device

Sep 2015

Decision

82d

Days

—

Risk

K151575 is an FDA 510(k) clearance for the Dynarex Eye Cups. This device is classified as a Cup, Eye.

Submitted by Dynarex Corporation (Orangeburg, US). The FDA issued a Cleared decision on September 1, 2015, 82 days after receiving the submission on June 11, 2015.

This device falls under the Ophthalmic FDA review panel.

Submission Details

510(k) Number	K151575 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 11, 2015
Decision Date	September 01, 2015
Days to Decision	82 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF