The following data is part of a premarket notification filed by Pascal Co., Inc. with the FDA for Hydent.
Device ID | K911259 |
510k Number | K911259 |
Device Name: | HYDENT |
Classification | Paper, Articulation |
Applicant | PASCAL CO., INC. P.O. BOX 1478 Bellevue, WA 98009 |
Contact | Joe Pellicano |
Correspondent | Joe Pellicano PASCAL CO., INC. P.O. BOX 1478 Bellevue, WA 98009 |
Product Code | EFH |
CFR Regulation Number | 872.6140 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-03-22 |
Decision Date | 1991-06-06 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
HYDENT 71465999 0409904 Dead/Expired |
BURNDY ENGINEERING COMPANY, INC. 1943-12-23 |