Medical Device Manufacturer · US , New Port Richey , FL

Bergen Mfg. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 1986

Recent clearances: BERGEN MODEL 500 ELECTROSURGERY GENERATOR, BERGEN 610 BIPOLAR COAGULATOR

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Bergen Mfg. General & Plastic Surgery ✕

4 devices

1-4 of 4

Cleared Aug 27, 1997

BERGEN MODEL 500 ELECTROSURGERY GENERATOR

General & Plastic Surgery · 69d

Cleared Feb 27, 1997

BERGEN 610 BIPOLAR COAGULATOR

General & Plastic Surgery · 94d

Cleared Mar 01, 1995

General & Plastic Surgery · 90d

Cleared Oct 14, 1986

MODEL 709 BIPOLAR MICRO COAGULATOR

General & Plastic Surgery · 21d