The following data is part of a premarket notification filed by Scientific Device Manufacturer Llc. with the FDA for Pressure Stopcock/manifold.
Device ID | K960431 |
510k Number | K960431 |
Device Name: | PRESSURE STOPCOCK/MANIFOLD |
Classification | Set, Administration, Intravascular |
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 | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-01-31 |
Decision Date | 1996-10-29 |
Summary: | summary |