Cleared Traditional

K952597 - VIEW POINT, DORION, RUDDY PROJECT, ULTRA FLEX, TRILLON, BAY BOY, SHIELD SKI, SUN POCKETS, POINT OF VIEW
(FDA 510(k) Clearance)

K952597 · Point of View Optical Outlet, Inc. · Ophthalmic device

Sep 1995

Decision

98d

Days

Class 1

Risk

K952597 is an FDA 510(k) clearance for the VIEW POINT, DORION, RUDDY PROJECT, ULTRA FLEX, TRILLON, BAY BOY, SHIELD SKI, SUN POCKETS, POINT OF VIEW. This device is classified as a Frame, Spectacle (Class I - General Controls, product code HQZ).

Submitted by Point of View Optical Outlet, Inc. (Aventura, US). The FDA issued a Cleared decision on September 12, 1995, 98 days after receiving the submission on June 6, 1995.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5842.

Submission Details

510(k) Number	K952597 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 06, 1995
Decision Date	September 12, 1995
Days to Decision	98 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Statement