The following data is part of a premarket notification filed by Pdo Max, Inc. with the FDA for Pdo Max Suture With Dual Needle.
| Device ID | K210871 |
| 510k Number | K210871 |
| Device Name: | PDO Max Suture With Dual Needle |
| Classification | Suture, Surgical, Absorbable, Polydioxanone |
| Applicant | PDO MAX, Inc. 4971 Bear Road Liverpool, NY 13088 |
| Contact | Giovanna Mccarthy |
| Correspondent | Mary Vater Medical Device Academy, Inc. 345 Lincoln Hill Rd. Shrewsbury, VT 05738 |
| Product Code | NEW |
| CFR Regulation Number | 878.4840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-24 |
| Decision Date | 2021-12-17 |