The following data is part of a premarket notification filed by Arc Medical Supplies (beijing) Co, Ltd. with the FDA for Pdo (polydioxanone) Monofilament Synthetic Absorbable Suture U.s.p..
| Device ID | K022666 |
| 510k Number | K022666 |
| Device Name: | PDO (POLYDIOXANONE) MONOFILAMENT SYNTHETIC ABSORBABLE SUTURE U.S.P. |
| Classification | Suture, Surgical, Absorbable, Polydioxanone |
| Applicant | ARC MEDICAL SUPPLIES (BEIJING) CO, LTD. 1591 S. MOORLAND RD. SUITE 104 New Berlin, WI 53151 |
| Contact | Charles F Andrews |
| Correspondent | Charles F Andrews ARC MEDICAL SUPPLIES (BEIJING) CO, LTD. 1591 S. MOORLAND RD. SUITE 104 New Berlin, WI 53151 |
| Product Code | NEW |
| CFR Regulation Number | 878.4840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-09 |
| Decision Date | 2002-10-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20814639023842 | K022666 | 000 |
| 10814639025979 | K022666 | 000 |
| 10814639025986 | K022666 | 000 |
| 10814639025993 | K022666 | 000 |
| 10814639023272 | K022666 | 000 |
| 20814639022654 | K022666 | 000 |
| 20814639022661 | K022666 | 000 |
| 20814639022678 | K022666 | 000 |
| 20814639022685 | K022666 | 000 |
| 20814639022692 | K022666 | 000 |
| 20814639022708 | K022666 | 000 |
| 20814639022715 | K022666 | 000 |
| 20814639023774 | K022666 | 000 |
| 20814639023835 | K022666 | 000 |
| 10814639025962 | K022666 | 000 |