The following data is part of a premarket notification filed by Cdb Corporation with the FDA for Cdb Clip.
Device ID | K080906 |
510k Number | K080906 |
Device Name: | CDB CLIP |
Classification | Bracket, Ceramic, Orthodontic |
Applicant | CDB CORPORATION 9201 INDUSTRIAL BLVD. Leland, NC 28451 |
Contact | Jens Rumsfeld |
Correspondent | Jens Rumsfeld CDB CORPORATION 9201 INDUSTRIAL BLVD. Leland, NC 28451 |
Product Code | NJM |
CFR Regulation Number | 872.5470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-04-01 |
Decision Date | 2008-10-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
D80721111111 | K080906 | 000 |