The following data is part of a premarket notification filed by Nissho Iwai American Corp. with the FDA for Denpax.
| Device ID | K860058 |
| 510k Number | K860058 |
| Device Name: | DENPAX |
| Classification | Unit, Suction Operatory |
| Applicant | NISSHO IWAI AMERICAN CORP. 1211 AVE. OF THE AMERICAS New York, NY 10036 |
| Contact | Liu |
| Correspondent | Liu NISSHO IWAI AMERICAN CORP. 1211 AVE. OF THE AMERICAS New York, NY 10036 |
| Product Code | EBR |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-06 |
| Decision Date | 1986-03-12 |