510(k) K780409
- Device
- COLOPLAST-DURASEAL OSTOMY APPLIANCE
- Applicant
- C.R. BARD, INC.
- 510(k) number
- K780409
- Product code
- EZS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-04-27
- Date received
- 1978-03-13
- Regulation
- 876.5900
- Classification name
- Appliance, Colostomy, Disposable
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 110 Marshall Dr. Warrendale PA US 15086 15086
FDA Registration Numbers#
- 9618003
- 3006210673
- 2320961
- 3010621964
- 3007311035
- 3013530901
- 2530957
- 3011987967
- 3005669815
- 3003767891
- 3008806809
- 3010521015
- 3014421917
- 3016615875
- 3013863160
- 3008244559
- 3010131137
- 9617198
- 2110898
- 3007417132
- 3011495142
- 1480288
- 1717046
- 1520020
- 3014615175
- 3012050423
- 3009167225
- 3008374791
- 3019682549
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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