The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for 1ml Luer-lok Syringe.
| Device ID | K941562 |
| 510k Number | K941562 |
| Device Name: | 1ML LUER-LOK SYRINGE |
| Classification | Syringe, Piston |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Contact | Don A Cutshall |
| Correspondent | Don A Cutshall 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 | 1994-04-01 |
| Decision Date | 1994-05-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50382903096287 | K941562 | 000 |
| 30680651467189 | K941562 | 000 |
| 30680651467196 | K941562 | 000 |
| 30680651467202 | K941562 | 000 |
| 30680651467318 | K941562 | 000 |
| 10193493924094 | K941562 | 000 |
| 10193493924100 | K941562 | 000 |
| 10193493924117 | K941562 | 000 |
| 10193493924216 | K941562 | 000 |
| 10193493985866 | K941562 | 000 |
| 10193493466990 | K941562 | 000 |
| 10193493468550 | K941562 | 000 |
| 10193493469403 | K941562 | 000 |
| 10193493965776 | K941562 | 000 |
| 10193493965790 | K941562 | 000 |
| 10193493965813 | K941562 | 000 |
| 30680651924217 | K941562 | 000 |