The following data is part of a premarket notification filed by Cp Medical Inc. with the FDA for C-ptfetm Surgical Suture.
| Device ID | K173922 |
| 510k Number | K173922 |
| Device Name: | C-PTFETM Surgical Suture |
| Classification | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene |
| Applicant | CP Medical Inc. 1775 Corporate Dr. Suite 150 Norcross, GA 30093 |
| Contact | John Hartigan |
| Correspondent | John Hartigan CP Medical Inc. 1775 Corporate Dr. Suite 150 Norcross, GA 30093 |
| Product Code | NBY |
| CFR Regulation Number | 878.5035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-26 |
| Decision Date | 2018-03-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889813025208 | K173922 | 000 |
| 00889813024980 | K173922 | 000 |
| 00889813025000 | K173922 | 000 |
| 00889813025024 | K173922 | 000 |
| 00889813025048 | K173922 | 000 |
| 00889813025062 | K173922 | 000 |
| 00889813025086 | K173922 | 000 |
| 00889813025109 | K173922 | 000 |
| 00889813025123 | K173922 | 000 |
| 00889813025147 | K173922 | 000 |
| 00889813025161 | K173922 | 000 |
| 00889813025185 | K173922 | 000 |
| 00889813024966 | K173922 | 000 |