The following data is part of a premarket notification filed by Argon Med. Productions Vertriebs Gesellschaft Mbh Co Kg with the FDA for K3pro Surgical Tray.
| Device ID | K160574 |
| 510k Number | K160574 |
| Device Name: | K3PRO SURGICAL TRAY |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | ARGON MED. PRODUCTIONS VERTRIEBS GESELLSCHAFT MBH CO KG MAINZER STR 346 Bingen Am Rhein, DE 55411 |
| Contact | Richard Donaca |
| Correspondent | Linda Saylor ARGON MEDICAL CORP. 1000 CORPORATE DR Marshfield, WI 54449 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-01 |
| Decision Date | 2016-12-20 |