The following data is part of a premarket notification filed by Atomic Products Corp. with the FDA for Dynaject.
Device ID | K790835 |
510k Number | K790835 |
Device Name: | DYNAJECT |
Classification | Injector And Syringe, Angiographic |
Applicant | ATOMIC PRODUCTS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DXT |
CFR Regulation Number | 870.1650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-04-30 |
Decision Date | 1979-06-22 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DYNAJECT 73298353 not registered Dead/Abandoned |
ATOMIC PRODUCTS CORPORATION 1981-02-23 |