OPTHALMIC BAR PRISM— 510(k) K851555

Substantially Equivalent

Roseburg SA

FDA 510(k) clearance K851555 for OPTHALMIC BAR PRISM, Substantially Equivalent on 1985-05-23. Applicant: Roseburg SA. Device class: 1.

Clearance details

Applicant: Roseburg SA
Product code: Code HKW
Device class: Class 1
Regulation: 21 CFR 886.1650
Advisory panel: Ophthalmic
Date received: 1985-04-16
Decision date: 1985-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HKW

K911374 — PLASTIC OVERLAYS1991-07-26

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.