ORVIS KEY WEST SUNGLASSES— 510(k) K950609

Substantially Equivalent

The Orvis Co., Inc.

FDA 510(k) clearance K950609 for ORVIS KEY WEST SUNGLASSES, Substantially Equivalent on 1995-03-02. Applicant: The Orvis Co., Inc.. Device class: 1.

Clearance details

Applicant: The Orvis Co., Inc.
Product code: Code HQY
Device class: Class 1
Regulation: 21 CFR 886.5850
Advisory panel: Ophthalmic
Date received: 1995-02-10
Decision date: 1995-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Manchester, VT, 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 The Orvis Co., Inc.

K943161 — ORVIS DRIVING GLASSES1994-08-04
K942951 — ORVIS LIGHT WEIGHT POLARIZED CLIP-ONS1994-08-02
K943131 — ORVIS POLARIZED BI-FOCALS1994-08-02
K942952 — ORVIS WORLD FINEST POLARIZED CLIP ONS1994-07-25
K941910 — SUNGLASSES1994-07-08

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