U108, U105, G209-B— 510(k) K925224

Substantially Equivalent

Custom Optical Frames, Inc.

FDA 510(k) clearance K925224 for U108, U105, G209-B, Substantially Equivalent on 1993-09-01. 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: 1992-10-16
Decision date: 1993-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, 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

More clearances from Custom Optical Frames, Inc.

K970895 — CUSTOM OPTICAL SUNGLASS FRAMES1997-05-06
K962478 — (BRAND NAME) SUNGLASS FRAMES1996-07-25
K944373 — SPECTACLE FRAMES1994-09-28

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