CALIUS-ISABEL CANOVAS SUNGLASSES— 510(k) K890081

Substantially Equivalent

Roseburg SA

FDA 510(k) clearance K890081 for CALIUS-ISABEL CANOVAS SUNGLASSES, Substantially Equivalent on 1989-03-09. Applicant: Roseburg SA. Device class: 1.

Clearance details

Applicant: Roseburg SA
Product code: Code HQY
Device class: Class 1
Regulation: 21 CFR 886.5850
Advisory panel: Ophthalmic
Date received: 1989-01-10
Decision date: 1989-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HQY

K974852 — NON-PRESCRIPTION SUNGLASSES1998-01-30
K974860 — NON-PRESCRIPTION SUNGLASSES1998-01-30
K974861 — NON-PRESCRIPTION SUNGLASSES1998-01-27
K974511 — SUNGLASSES1998-01-12
K974441 — SUNGLASSES1998-01-09

More clearances from Roseburg SA

K931155 — STAPLE, FIXATION BONE; SCREW FIXATION BONE1994-09-01
K885275 — ASSENAT-BLESCHET SUNGLASSES1989-01-24
K882392 — BURNET LABORATOIRE PHARMACEUTIQUE SURGICAL GLOVES1988-08-26
K872715 — UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY1987-12-07
K874317 — POIRIER KID-ROLLER MANUAL WHEELCHAIR1987-11-17

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