BARAKKA, INFERNO, STERLING, AND/OR ONE— 510(k) K970944

Name: FDA 510(k) clearance K970944
Creator: U.S. Food and Drug Administration
Published: 1997-05-06

Substantially Equivalent

Sentinal Importing Corp.

FDA 510(k) clearance K970944 for BARAKKA, INFERNO, STERLING, AND/OR ONE, Substantially Equivalent on 1997-05-06. Applicant: Sentinal Importing Corp.. Device class: 1.

Clearance details

Applicant: Sentinal Importing Corp.
Product code: Code HQY
Device class: Class 1
Regulation: 21 CFR 886.5850
Advisory panel: Ophthalmic
Date received: 1997-03-13
Decision date: 1997-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Vancouver, B.C., CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code HQY

view all

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.