Medical Device Manufacturer · US , Uniontown , PA

Berkley Medical Resources, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 1996

Recent clearances: FLOOR MASK-EAR LOOP(BMR-15011)/FLOOR MASK-TIE(BMR-1503)

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Berkley Medical Resources, Inc. General Hospital ✕

2 devices

1-2 of 2

Cleared Jul 28, 1997

FLOOR MASK-EAR LOOP(BMR-15011)/FLOOR MASK-TIE(BMR-1503)

General Hospital · 77d

Cleared Oct 07, 1996

2505 FACE MASK, TIE STRING / ANTI-FOG / FACE SHIELD

General Hospital · 115d