The following data is part of a premarket notification filed by Coloplast Corp. with the FDA for Coloplast Ostomy Rod, Model 12814.
| Device ID | K052229 |
| 510k Number | K052229 |
| Device Name: | COLOPLAST OSTOMY ROD, MODEL 12814 |
| Classification | Rod, Colostomy |
| Applicant | COLOPLAST CORP. 1940 COMMERCE DR. North Mankato, MN 56003 |
| Contact | Elizabeth Boots |
| Correspondent | Elizabeth Boots COLOPLAST CORP. 1940 COMMERCE DR. North Mankato, MN 56003 |
| Product Code | EZP |
| CFR Regulation Number | 876.4270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-16 |
| Decision Date | 2006-10-13 |
| Summary: | summary |