Medical Device Manufacturer · US , Grand Junction , CO

American Biocurve, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2001

Recent clearances: BIOCURVE SOFT (HIOXIFILCON B) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND BLUE VISIBILITY-HANDLING L, BIOCURVE SOFT (METHAFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR & BLUE VISIBILITY TINT, LATHE

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - American Biocurve, Inc. Ophthalmic ✕

2 devices

1-2 of 2

Cleared Jun 13, 2001

BIOCURVE SOFT (HIOXIFILCON B) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY...

Ophthalmic · 51d

Cleared Feb 13, 2001

BIOCURVE SOFT (METHAFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY...

Ophthalmic · 267d