The following data is part of a premarket notification filed by Wonder Wire with the FDA for Orthodontic Arch.
Device ID | K872622 |
510k Number | K872622 |
Device Name: | ORTHODONTIC ARCH |
Classification | Knife, Margin Finishing, Operative |
Applicant | WONDER WIRE P.O. BOX 6499 Wyomissing, PA 19610 |
Contact | Wool, Dds |
Correspondent | Wool, Dds WONDER WIRE P.O. BOX 6499 Wyomissing, PA 19610 |
Product Code | EJZ |
CFR Regulation Number | 872.4565 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-07-06 |
Decision Date | 1987-10-09 |