The following data is part of a premarket notification filed by Arthrotek, Inc. with the FDA for Maxbraid Polyester Plus And Polyethylene Plus Suture.
| Device ID | K033718 |
| 510k Number | K033718 |
| Device Name: | MAXBRAID POLYESTER PLUS AND POLYETHYLENE PLUS SUTURE |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | ARTHROTEK, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Patricia Sandborn Beres |
| Correspondent | Patricia Sandborn Beres ARTHROTEK, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-26 |
| Decision Date | 2004-02-12 |
| Summary: | summary |