CUSTOM OPTICAL SUNGLASS FRAMES— 510(k) K970895

Name: FDA 510(k) clearance K970895
Creator: U.S. Food and Drug Administration
Published: 1997-05-06

Substantially Equivalent

Custom Optical Frames, Inc.

FDA 510(k) clearance K970895 for CUSTOM OPTICAL SUNGLASS FRAMES, Substantially Equivalent on 1997-05-06. Applicant: Custom Optical Frames, Inc.. Device class: 1.

Clearance details

Applicant: Custom Optical Frames, Inc.
Product code: Code HQY
Device class: Class 1
Regulation: 21 CFR 886.5850
Advisory panel: Ophthalmic
Date received: 1997-03-11
Decision date: 1997-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HQY

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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

More clearances from Custom Optical Frames, Inc.

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K962478 — (BRAND NAME) SUNGLASS FRAMES1996-07-25
K944373 — SPECTACLE FRAMES1994-09-28
K925224 — U108, U105, G209-B1993-09-01

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