Medical Device Manufacturer · US , Washington , DC

Roseburg SA - FDA 510(k) Cleared Devices

24 submissions · 23 cleared · Since 1985

24

Total

23

Cleared

0

Denied

FDA 510(k) Regulatory Record - Roseburg SA Ophthalmic ✕

8 devices

1-8 of 8

Cleared Mar 09, 1989

CALIUS-ISABEL CANOVAS SUNGLASSES

Ophthalmic · 58d

Cleared Jan 24, 1989

ASSENAT-BLESCHET SUNGLASSES

Ophthalmic · 28d

Cleared May 29, 1987

SPECTACLE FRAME - DANIELLE

Ophthalmic · 30d

Cleared May 29, 1987

SPECTACLE FRAME - LORRAINE

Ophthalmic · 30d

Cleared Oct 24, 1986

SUNGLASSES (NON-PRESCRIPTION)

Ophthalmic · 225d

Cleared Mar 31, 1986

SPECTACLES FRAME

Ophthalmic · 18d

Cleared Mar 31, 1986

SPECTACLES LENS

Ophthalmic · 18d

Cleared May 23, 1985

OPTHALMIC BAR PRISM

Ophthalmic · 37d