The following data is part of a premarket notification filed by Wilde-usa, Inc. with the FDA for Wilde Auxiliaries.
Device ID | K912991 |
510k Number | K912991 |
Device Name: | WILDE AUXILIARIES |
Classification | Resin, Denture, Relining, Repairing, Rebasing |
Applicant | WILDE-USA, INC. P.O. BOX 4168 Naperville, IL 60567 |
Contact | Robert W Bauer |
Correspondent | Robert W Bauer WILDE-USA, INC. P.O. BOX 4168 Naperville, IL 60567 |
Product Code | EBI |
CFR Regulation Number | 872.3760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-07-08 |
Decision Date | 1991-12-19 |