ROCCOBAROCCO & PRO-DYNAMIX— 510(k) K965170

Substantially Equivalent

Michelangelo, Inc.

FDA 510(k) clearance K965170 for ROCCOBAROCCO & PRO-DYNAMIX, Substantially Equivalent on 1997-03-11. Applicant: Michelangelo, Inc.. Device class: 1.

Clearance details

Applicant: Michelangelo, Inc.
Product code: Code HQY
Device class: Class 1
Regulation: 21 CFR 886.5850
Advisory panel: Ophthalmic
Date received: 1996-12-24
Decision date: 1997-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boynton Beach, FL, 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.