510(k) K052229
- Device
- COLOPLAST OSTOMY ROD, MODEL 12814
- Applicant
- COLOPLAST CORP.
- 510(k) number
- K052229
- Product code
- EZP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-10-13
- Date received
- 2005-08-16
- Regulation
- 876.4270
- Classification name
- Rod, Colostomy
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ELIZABETH BOOTS
- Address
- 1940 Commerce Dr. North Mankato MN US 56003 56003
FDA Registration Numbers#
- 1058584
- 3013530901
- 3012421607
- 1520020
- 3043041723
- 9618003
- 9610694
- 3006606901
- 3011987967
- 3004550973
- 1480288
- 2320961
- 3008806809
- 1000317571
- 3007417132
- 1047843
- 3008262278
Source Documents#
Other 510(k) Records For Product Code EZP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K040110 | EASY LOOP, MODEL EZL-01 | Tools For Surgery, LLC | 2004-03-24 |
Legacy Summary#
summary
FDA Review#
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