Cleared Traditional

K913081 - MULTI-VIEW BIFOCALS
(FDA 510(k) Clearance)

K913081 · Camp Contact Lenses · Ophthalmic device

Oct 1991

Decision

107d

Days

—

Risk

K913081 is an FDA 510(k) clearance for the MULTI-VIEW BIFOCALS. This device is classified as a Lens, Contact (polymethylmethacrylate).

Submitted by Camp Contact Lenses (Houston, US). The FDA issued a Cleared decision on October 23, 1991, 107 days after receiving the submission on July 8, 1991.

This device falls under the Ophthalmic FDA review panel.

Submission Details

510(k) Number	K913081 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 08, 1991
Decision Date	October 23, 1991
Days to Decision	107 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Statement