The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Becton Dickinson Syringes.
Device ID | K980580 |
510k Number | K980580 |
Device Name: | BECTON DICKINSON SYRINGES |
Classification | Syringe, Piston |
Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
Contact | Peter Zurio |
Correspondent | Peter Zurio BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-02-17 |
Decision Date | 1998-06-25 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
30382903033448 | K980580 | 000 |