The following data is part of a premarket notification filed by Cp Medical with the FDA for Mono-dox, Synthetic Absorbable Polydioxanone Surgical Suture,sterile.
| Device ID | K013274 |
| 510k Number | K013274 |
| Device Name: | MONO-DOX, SYNTHETIC ABSORBABLE POLYDIOXANONE SURGICAL SUTURE,STERILE |
| Classification | Suture, Surgical, Absorbable, Polydioxanone |
| Applicant | CP MEDICAL 836 N.E. 24TH AVE. Portland, OR 97232 |
| Contact | Mary Ann Greenawalt |
| Correspondent | Mary Ann Greenawalt CP MEDICAL 836 N.E. 24TH AVE. Portland, OR 97232 |
| Product Code | NEW |
| CFR Regulation Number | 878.4840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-01 |
| Decision Date | 2001-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10790986006390 | K013274 | 000 |
| 20790986001132 | K013274 | 000 |
| 20790986001125 | K013274 | 000 |
| 20790986001118 | K013274 | 000 |
| 20790986001101 | K013274 | 000 |
| 20790986001095 | K013274 | 000 |
| 20790986001088 | K013274 | 000 |
| 20790986001071 | K013274 | 000 |
| 20790986001057 | K013274 | 000 |
| 20790986001040 | K013274 | 000 |
| 20790986001033 | K013274 | 000 |
| 20790986001026 | K013274 | 000 |
| 20790986001019 | K013274 | 000 |
| 20790986001149 | K013274 | 000 |
| 20790986001156 | K013274 | 000 |
| 10790986006383 | K013274 | 000 |
| 20790986001279 | K013274 | 000 |
| 20790986001262 | K013274 | 000 |
| 20790986001255 | K013274 | 000 |
| 20790986001248 | K013274 | 000 |
| 20790986001231 | K013274 | 000 |
| 20790986001224 | K013274 | 000 |
| 20790986001217 | K013274 | 000 |
| 20790986001200 | K013274 | 000 |
| 20790986001194 | K013274 | 000 |
| 20790986001187 | K013274 | 000 |
| 20790986001163 | K013274 | 000 |
| 10790986001005 | K013274 | 000 |