The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Digitex Suture Delivery System, Digitexpolypropylene Suture Cartridge Size 0, With Needle And Without Needle, Digitex.
| Device ID | K120284 |
| 510k Number | K120284 |
| Device Name: | DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEX |
| Classification | Suture, Surgical, Absorbable, Polydioxanone |
| Applicant | COLOPLAST A/S 1601 WEST RIVER ROAD NORTH Minneapolis, MN 55411 |
| Contact | Janell Colley |
| Correspondent | Janell Colley COLOPLAST A/S 1601 WEST RIVER ROAD NORTH Minneapolis, MN 55411 |
| Product Code | NEW |
| CFR Regulation Number | 878.4840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-31 |
| Decision Date | 2012-05-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05708932504089 | K120284 | 000 |
| 05708932504058 | K120284 | 000 |
| 05708932504027 | K120284 | 000 |
| 05708932503990 | K120284 | 000 |