Medical Device Manufacturer · US , Golden , CO

Dentsleeve Pty., Ltd. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 1998

Recent clearances: MANOMETRIC ASSEMBLIES, MARK II CO2 FLUSH MANOMETRIC PERFUSION PUMP & MARK II MANOMETRIC PERFUSION PUMP

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Dentsleeve Pty., Ltd. Gastroenterology & Urology ✕

3 devices

1-3 of 3

Cleared Oct 19, 2001

MARK II/MARK III MANOMETRIC PERFUSION PUMP

Gastroenterology & Urology · 29d

Cleared May 17, 1999

MANOMETRIC ASSEMBLIES

Gastroenterology & Urology · 210d

Cleared Jun 08, 1998

MARK II CO2 FLUSH MANOMETRIC PERFUSION PUMP & MARK II MANOMETRIC PERFUSION PUMP

Gastroenterology & Urology · 87d