SPECTACLE FRAME— 510(k) K943084

Substantially Equivalent

Samil Enterprise Co.

FDA 510(k) clearance K943084 for SPECTACLE FRAME, Substantially Equivalent on 1994-07-25. Applicant: Samil Enterprise Co.. Device class: 1.

Clearance details

Applicant: Samil Enterprise Co.
Product code: Code HQZ
Device class: Class 1
Regulation: 21 CFR 886.5842
Advisory panel: Ophthalmic
Date received: 1994-06-28
Decision date: 1994-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baltimore, MD, 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.