The following data is part of a premarket notification filed by Becton, Dickinson & Company with the FDA for Bd Ultra-fine™ Insulin Syringe, Bd Ultra-fine™ Ii Insulin Syringe, Bd Insulin Syringes With The Bd Ultra-fine™ Needle And Bd Insulin Syringes With Micro-fine™ Iv Needle.
Device ID | K170386 |
510k Number | K170386 |
Device Name: | BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe, BD Insulin Syringes With The BD Ultra-Fine™ Needle And BD Insulin Syringes With Micro-Fine™ IV Needle |
Classification | Syringe, Piston |
Applicant | Becton, Dickinson & Company 1 Becton Drive Franklin Lakes, NJ 07666 |
Contact | Riddhish Patel |
Correspondent | Riddhish Patel Becton, Dickinson & Company 1 Becton Drive Franklin Lakes, NJ 07666 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-02-08 |
Decision Date | 2017-04-12 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BD ULTRA-FINE 78717623 3320459 Dead/Cancelled |
Becton, Dickinson and Company 2005-09-21 |