The following data is part of a premarket notification filed by Bego Implant Systems Gmbh & Co. Kg with the FDA for Bego Semados Tr 58350; Bego Semados Rs/rsx-line Tray Plus, Bego Semados Tr 58349; Bego Semados Tr 58348, Bego Semados Dstr 58356; Drill Stop Tray Plus (rs/rsx-line), Bego Semados Pktr 58357; Prosthetic Kit.
Device ID | K201412 |
510k Number | K201412 |
Device Name: | BEGO SEMADOS Tr 58350; BEGO SEMADOS RS/RSX-Line Tray Plus, BEGO Semados Tr 58349; BEGO Semados Tr 58348, BEGO Semados DSTr 58356; Drill Stop Tray Plus (RS/RSX-Line), BEGO SEMADOS PKTr 58357; Prosthetic Kit |
Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
Applicant | BEGO Implant Systems GmbH & Co. KG Wilhelm-Herbst-Str. 1 Bremen, DE 28359 |
Contact | Bertrand Lecointe |
Correspondent | Bertrand Lecointe BEGO Implant Systems GmbH & Co. KG Wilhelm-Herbst-Str. 1 Bremen, DE 28359 |
Product Code | KCT |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-05-28 |
Decision Date | 2021-02-18 |