SPECTACLES FRAME— 510(k) K860954

Substantially Equivalent

Roseburg SA

FDA 510(k) clearance K860954 for SPECTACLES FRAME, Substantially Equivalent on 1986-03-31. Applicant: Roseburg SA. Device class: 1.

Clearance details

Applicant: Roseburg SA
Product code: Code HQZ
Device class: Class 1
Regulation: 21 CFR 886.5842
Advisory panel: Ophthalmic
Date received: 1986-03-13
Decision date: 1986-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, 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 Roseburg SA

K931155 — STAPLE, FIXATION BONE; SCREW FIXATION BONE1994-09-01
K890081 — CALIUS-ISABEL CANOVAS SUNGLASSES1989-03-09
K885275 — ASSENAT-BLESCHET SUNGLASSES1989-01-24
K882392 — BURNET LABORATOIRE PHARMACEUTIQUE SURGICAL GLOVES1988-08-26
K872715 — UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY1987-12-07

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