SEIKO P-2 & SEIKO P-3 (SPECTACLE LENS)— 510(k) K861684

Name: FDA 510(k) clearance K861684
Creator: U.S. Food and Drug Administration
Published: 1986-06-09

Substantially Equivalent

Seiko Optical Products of America, Inc.

FDA 510(k) clearance K861684 for SEIKO P-2 & SEIKO P-3 (SPECTACLE LENS), Substantially Equivalent on 1986-06-09. Applicant: Seiko Optical Products of America, Inc.. Device class: 1.

Clearance details

Applicant: Seiko Optical Products of America, Inc.
Product code: Code HQG
Device class: Class 1
Regulation: 21 CFR 886.5844
Advisory panel: Ophthalmic
Date received: 1986-05-02
Decision date: 1986-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mahwah, NJ, US

Download summary PDF View on FDA.gov ↗

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