The following data is part of a premarket notification filed by Becton Dickinson & Co. with the FDA for Heparin Lock Flush Solution, Usp Bd Posiflush Heparin Lock Flush Syringe.
Device ID | K090680 |
510k Number | K090680 |
Device Name: | HEPARIN LOCK FLUSH SOLUTION, USP BD POSIFLUSH HEPARIN LOCK FLUSH SYRINGE |
Classification | Heparin, Vascular Access Flush |
Applicant | BECTON DICKINSON & CO. 1 BECTON DRIVE MC237 Franklin Lakes, NJ 07417 |
Contact | John Roberts |
Correspondent | John Roberts BECTON DICKINSON & CO. 1 BECTON DRIVE MC237 Franklin Lakes, NJ 07417 |
Product Code | NZW |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2009-03-16 |
Decision Date | 2009-06-10 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
50382903064248 | K090680 | 000 |
50382903064231 | K090680 | 000 |
50382903064149 | K090680 | 000 |
50382903064132 | K090680 | 000 |