The following data is part of a premarket notification filed by Kulzer, Inc. with the FDA for Palavit L.
| Device ID | K905058 |
| 510k Number | K905058 |
| Device Name: | PALAVIT L |
| Classification | Material, Impression Tray, Resin |
| Applicant | KULZER, INC. 10005 MUIRLANDS BLVD. UNIT G. Irvine, CA 92718 |
| Contact | Sharon Parker |
| Correspondent | Sharon Parker 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 | 1990-11-08 |
| Decision Date | 1991-06-06 |