The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Bd Micro Fine, Ultra Fine, And Allergy Syringe.
| Device ID | K941657 |
| 510k Number | K941657 |
| Device Name: | BD MICRO FINE, ULTRA FINE, AND ALLERGY 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 | 1994-04-05 |
| Decision Date | 1994-05-26 |