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 |