KOELN OPTIK— 510(k) K862503

Substantially Equivalent

South West Intl., Inc.

FDA 510(k) clearance K862503 for KOELN OPTIK, Substantially Equivalent on 1986-07-11. Applicant: South West Intl., Inc.. Device class: 1.

Clearance details

Applicant: South West Intl., Inc.
Product code: Code HQZ
Device class: Class 1
Regulation: 21 CFR 886.5842
Advisory panel: Ophthalmic
Date received: 1986-07-01
Decision date: 1986-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mobile, AL, 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 South West Intl., Inc.

K862502 — MASUNAGA OPTICAL MANUFACTURING1986-07-11
K854343 — SIOM1985-11-12
K851661 — SOLEX & SAXON INT'L OPTICAL OF HONG KONG1985-05-30

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