510(k) K770408
- Device
- KARAYA GUM POWDER, OSTOMY
- Applicant
- Howmedica Corp.
- 510(k) number
- K770408
- Product code
- EZK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-03-15
- Date received
- 1977-03-04
- Regulation
- 876.5980
- Classification name
- Catheter, Retention Type
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 9612030
- 3012307300
- 3010291427
Source Documents#
510(k) summary PDF not indicated by FDA