510(k) K781736
- Device
- Disc, Coloplast Pre-op Stoma
- Applicant
- C.R. BARD, INC.
- 510(k) number
- K781736
- Product code
- EXA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-11-03
- Date received
- 1978-10-12
- Regulation
- 876.5900
- Classification name
- Selector, Size, Ostomy
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 9617198
- 3007417132
- 3014016843
Source Documents#
510(k) summary PDF not indicated by FDA