The following data is part of a premarket notification filed by Scientific Device Manufacturer Llc. with the FDA for Control Syringe.
Device ID | K960430 |
510k Number | K960430 |
Device Name: | CONTROL SYRINGE |
Classification | Injector And Syringe, Angiographic |
Applicant | SCIENTIFIC DEVICE MANUFACTURER LLC. 999 ANDERSEN DRIVE, SUITE 120 San Rafael, CA 94901 |
Contact | Richard C Ball |
Correspondent | Richard C Ball SCIENTIFIC DEVICE MANUFACTURER LLC. 999 ANDERSEN DRIVE, SUITE 120 San Rafael, CA 94901 |
Product Code | DXT |
CFR Regulation Number | 870.1650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-01-31 |
Decision Date | 1996-08-06 |
Summary: | summary |