KMANZ II— 510(k) K955611

Substantially Equivalent

Gatorz LLC

FDA 510(k) clearance K955611 for KMANZ II, Substantially Equivalent on 1996-01-03. Applicant: Gatorz LLC. Device class: 1.

Clearance details

Applicant: Gatorz LLC
Product code: Code HQY
Device class: Class 1
Regulation: 21 CFR 886.5850
Advisory panel: Ophthalmic
Date received: 1995-12-08
Decision date: 1996-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, 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.