The following data is part of a premarket notification filed by Cbs Intl. B.v. with the FDA for Cbw Bridge System (consisting Of Cbw Andchors, Cbw Micro-handpiece And Burs).
Device ID | K002693 |
510k Number | K002693 |
Device Name: | CBW BRIDGE SYSTEM (CONSISTING OF CBW ANDCHORS, CBW MICRO-HANDPIECE AND BURS) |
Classification | Pin, Retentive And Splinting, And Accessory Instruments |
Applicant | CBS INTL. B.V. GROTE MARKET 3-5 Almere, NL 1315 Ja |
Contact | Patricia E Jansen |
Correspondent | Patricia E Jansen CBS INTL. B.V. GROTE MARKET 3-5 Almere, NL 1315 Ja |
Product Code | EBL |
CFR Regulation Number | 872.3740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-08-29 |
Decision Date | 2000-11-09 |