Medical Device Manufacturer · US , Mchenry , IL

Holter-Hausner Intl. - FDA 510(k) Cleared Devices

42 submissions · 38 cleared · Since 1978

42

Total

38

Cleared

0

Denied

FDA 510(k) Regulatory Record - Holter-Hausner Intl. Gastroenterology & Urology ✕

3 devices

1-3 of 3

Cleared Aug 27, 1985

H-H SEXTON SCUP URINE MGMT. SYS

Gastroenterology & Urology · 11d

Cleared Oct 04, 1984

SEXTON CYSTOTOMY URINE PUMP

Gastroenterology & Urology · 55d

Cleared May 28, 1982

H-H ALIMENTATION CATHETERS

Gastroenterology & Urology · 46d