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 |