POLAREX AND POLAREX MLD— 510(k) K863651

Substantially Equivalent

Selex, Inc.

FDA 510(k) clearance K863651 for POLAREX AND POLAREX MLD, Substantially Equivalent on 1986-10-10. Applicant: Selex, Inc.. Device class: 1.

Clearance details

Applicant: Selex, Inc.
Product code: Code HQY
Device class: Class 1
Regulation: 21 CFR 886.5850
Advisory panel: Ophthalmic
Date received: 1986-09-18
Decision date: 1986-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Doraville, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HQY

K974852 — NON-PRESCRIPTION SUNGLASSES1998-01-30
K974860 — NON-PRESCRIPTION SUNGLASSES1998-01-30
K974861 — NON-PRESCRIPTION SUNGLASSES1998-01-27
K974511 — SUNGLASSES1998-01-12
K974441 — SUNGLASSES1998-01-09

Data sourced from openFDA. This site is unofficial and independent of the FDA.