The following data is part of a premarket notification filed by Kulzer, Inc. with the FDA for Palatray Lc Resin Impression Tray Material.
| Device ID | K902350 |
| 510k Number | K902350 |
| Device Name: | PALATRAY LC RESIN IMPRESSION TRAY MATERIAL |
| Classification | Material, Impression Tray, Resin |
| Applicant | KULZER, INC. 10005 MUIRLANDS BLVD. UNIT G. Irvine, CA 92718 |
| Contact | Barbara J Brown |
| Correspondent | Barbara J Brown KULZER, INC. 10005 MUIRLANDS BLVD. UNIT G. Irvine, CA 92718 |
| Product Code | EBH |
| CFR Regulation Number | 872.3670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-25 |
| Decision Date | 1990-07-26 |