The following data is part of a premarket notification filed by Kulzer, Inc. with the FDA for Paladon(r) 65.
Device ID | K901789 |
510k Number | K901789 |
Device Name: | PALADON(R) 65 |
Classification | Resin, Denture, Relining, Repairing, Rebasing |
Applicant | KULZER, INC. 680 N. LAKE SHORE DR. SUITE 901 Chicago, IL 60611 |
Contact | An-shih Cheng |
Correspondent | An-shih Cheng KULZER, INC. 680 N. LAKE SHORE DR. SUITE 901 Chicago, IL 60611 |
Product Code | EBI |
CFR Regulation Number | 872.3760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-04-19 |
Decision Date | 1990-06-22 |