E.M.A.— 510(k) K940614

Substantially Equivalent

European Manufacturers Agency, Inc.

FDA 510(k) clearance K940614 for E.M.A., Substantially Equivalent on 1994-04-06. Applicant: European Manufacturers Agency, Inc.. Device class: 1.

Clearance details

Applicant: European Manufacturers Agency, Inc.
Product code: Code HQZ
Device class: Class 1
Regulation: 21 CFR 886.5842
Advisory panel: Ophthalmic
Date received: 1994-02-14
Decision date: 1994-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clearwater, 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

More clearances from European Manufacturers Agency, Inc.

K940613 — E.M.A.1994-04-12
K940612 — E.M.A.1994-04-11

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