The following data is part of a premarket notification filed by Seikagaku Corp. with the FDA for Hadgel, 4 Gram/syringe.
| Device ID | K011544 |
| 510k Number | K011544 |
| Device Name: | HADGEL, 4 GRAM/SYRINGE |
| Classification | Splint, Intranasal Septal |
| Applicant | SEIKAGAKU CORP. 90 POTESKEET TRAIL Kitty Hawk, NC 27949 |
| Contact | John J Shea |
| Correspondent | John J Shea SEIKAGAKU CORP. 90 POTESKEET TRAIL Kitty Hawk, NC 27949 |
| Product Code | LYA |
| CFR Regulation Number | 874.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-18 |
| Decision Date | 2001-08-15 |