Cleared Traditional

SEIKO P-6 PROGRESSIVE SPECTACLE LENSES

K884360 · Seiko Corp. · Ophthalmic

Nov 1988

Decision

29d

Days

Class 1

Risk

About This 510(k) Submission

K884360 is an FDA 510(k) clearance for the SEIKO P-6 PROGRESSIVE SPECTACLE LENSES, a Lens, Spectacle, Non-custom (prescription) (Class I — General Controls, product code HQG), submitted by Seiko Corp. (Mahwah, US). The FDA issued a Cleared decision on November 15, 1988, 29 days after receiving the submission on October 17, 1988. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5844.

Submission Details

510(k) Number	K884360 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 17, 1988
Decision Date	November 15, 1988
Days to Decision	29 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—