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 |
| 00382903064243 | K090680 | 000 |
| 00382903064236 | K090680 | 000 |
| 00382903064144 | K090680 | 000 |
| 00382903064137 | K090680 | 000 |