DBA FOCAL CHANGE FRAMES— 510(k) K923415

Substantially Equivalent

Focal Change

FDA 510(k) clearance K923415 for DBA FOCAL CHANGE FRAMES, Substantially Equivalent on 1992-10-13. Applicant: Focal Change. Device class: 1.

Clearance details

Applicant: Focal Change
Product code: Code HQZ
Device class: Class 1
Regulation: 21 CFR 886.5842
Advisory panel: Ophthalmic
Date received: 1992-07-10
Decision date: 1992-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ardmore, PA, 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.