The following data is part of a premarket notification filed by Cdb Corp. with the FDA for Reflections.
Device ID | K973776 |
510k Number | K973776 |
Device Name: | REFLECTIONS |
Classification | Bracket, Plastic, Orthodontic |
Applicant | CDB CORP. 9201 INDUSTRIAL BLVD. Leland, NC 28451 |
Contact | Sylvia C Joyce |
Correspondent | Sylvia C Joyce CDB CORP. 9201 INDUSTRIAL BLVD. Leland, NC 28451 |
Product Code | DYW |
CFR Regulation Number | 872.5470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-10-03 |
Decision Date | 1997-11-21 |