SPECTACLE FRAMES— 510(k) K941523

Substantially Equivalent

Amore Mio, Inc.

FDA 510(k) clearance K941523 for SPECTACLE FRAMES, Substantially Equivalent on 1994-05-17. Applicant: Amore Mio, Inc.. Device class: 1.

Clearance details

Applicant: Amore Mio, Inc.
Product code: Code HQZ
Device class: Class 1
Regulation: 21 CFR 886.5842
Advisory panel: Ophthalmic
Date received: 1994-03-30
Decision date: 1994-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Coral Gables, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HQZ

K952597 — VIEW POINT, DORION, RUDDY PROJECT, ULTRA FLEX, TRILLON, BAY BOY, SHIELD SKI, SUN POCKETS, POINT OF VIEW1995-09-12
K944313 — SPECTACLE FRAME1995-03-28
K945176 — SPECTACLE FRAME OR EYEGLASS FRAMES1994-12-15
K945392 — SPECTACLE FRAME1994-12-15
K945770 — OPTICAL FRAMES1994-12-15

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