Cleared Traditional

K974860 - NON-PRESCRIPTION SUNGLASSES
(FDA 510(k) Clearance)

K974860 · Wenzhou Ming Ming Optical Co. , Ltd. · Ophthalmic device

Jan 1998

Decision

32d

Days

Class 1

Risk

K974860 is an FDA 510(k) clearance for the NON-PRESCRIPTION SUNGLASSES. This device is classified as a Sunglasses (non-prescription Including Photosensitive) (Class I - General Controls, product code HQY).

Submitted by Wenzhou Ming Ming Optical Co. , Ltd. (Wenzhou, Shejiang, CN). The FDA issued a Cleared decision on January 30, 1998, 32 days after receiving the submission on December 29, 1997.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5850.

Submission Details

510(k) Number	K974860 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 29, 1997
Decision Date	January 30, 1998
Days to Decision	32 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Statement