The following data is part of a premarket notification filed by Cp Medical with the FDA for Mono-swift.
| Device ID | K030786 |
| 510k Number | K030786 |
| Device Name: | MONO-SWIFT |
| 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 | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-12 |
| Decision Date | 2003-05-06 |
| Summary: | summary |