The following data is part of a premarket notification filed by Kulzer, Inc. with the FDA for Palapress(r) Vario Resin.
| Device ID | K902115 |
| 510k Number | K902115 |
| Device Name: | PALAPRESS(R) VARIO RESIN |
| 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 | 1990-05-10 |
| Decision Date | 1990-07-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| J014647078930 | K902115 | 000 |
| J014647078910 | K902115 | 000 |
| J014647078890 | K902115 | 000 |
| J014647147960 | K902115 | 000 |
| J014647078920 | K902115 | 000 |
| J014647078640 | K902115 | 000 |