The following data is part of a premarket notification filed by Kulzer, Inc. with the FDA for Palavit Glc.
Device ID | K904928 |
510k Number | K904928 |
Device Name: | PALAVIT GLC |
Classification | Wax, Dental, Intraoral |
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 | EGD |
CFR Regulation Number | 872.6890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-10-31 |
Decision Date | 1991-06-06 |