The following data is part of a premarket notification filed by Bd with the FDA for Bd Integra Syringe.
Device ID | K023752 |
510k Number | K023752 |
Device Name: | BD INTEGRA SYRINGE |
Classification | Syringe, Piston |
Applicant | BD ONE BECTON DRIVE MC226 Franklin Lakes, NJ 07417 |
Contact | Pasquale Amato |
Correspondent | Pasquale Amato BD ONE BECTON DRIVE MC226 Franklin Lakes, NJ 07417 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-11-08 |
Decision Date | 2003-02-07 |
Summary: | summary |