The following data is part of a premarket notification filed by Coloplast Manufacturing Us, Llc with the FDA for Digitex Suture Delivery System, Model 52025, Digitex Suture Cartridge (size O), Model 52026, Digitex Suture Cartridge.
| Device ID | K093112 |
| 510k Number | K093112 |
| Device Name: | DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE CARTRIDGE (SIZE O), MODEL 52026, DIGITEX SUTURE CARTRIDGE |
| Classification | Suture, Nonabsorbable, Synthetic, Polypropylene |
| Applicant | COLOPLAST MANUFACTURING US, LLC 1601 WEST RIVER ROAD Minneapolis, MN 55411 |
| Contact | Janell Colley |
| Correspondent | Kelley Breheim COLOPLAST MANUFACTURING US, LLC 1601 WEST RIVER ROAD Minneapolis, MN 55411 |
| Product Code | GAW |
| CFR Regulation Number | 878.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-01 |
| Decision Date | 2010-02-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05708932440219 | K093112 | 000 |
| 05708932440189 | K093112 | 000 |
| 05708932440134 | K093112 | 000 |