The following data is part of a premarket notification filed by Kulzer, Inc. with the FDA for Palaseal(r).
Device ID | K892452 |
510k Number | K892452 |
Device Name: | PALASEAL(R) |
Classification | Resin, Denture, Relining, Repairing, Rebasing |
Applicant | KULZER, INC. 111 N. WABASH AVE. Chicago, IL 60602 |
Contact | Bauer, Phd |
Correspondent | Bauer, Phd KULZER, INC. 111 N. WABASH AVE. Chicago, IL 60602 |
Product Code | EBI |
CFR Regulation Number | 872.3760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-04-10 |
Decision Date | 1989-06-16 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
J014647106140 | K892452 | 000 |
J014647080610 | K892452 | 000 |
J014647080630 | K892452 | 000 |