The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Emerald Saf-t Single Use, Hypodermic.
Device ID | K121283 |
510k Number | K121283 |
Device Name: | BD EMERALD SAF-T SINGLE USE, HYPODERMIC |
Classification | Syringe, Piston |
Applicant | Becton, Dickinson And Company 1 BECTON DRIVE MC237 Franklin Lakes, NJ 07417 |
Contact | Kimberly Lane |
Correspondent | Kimberly Lane Becton, Dickinson And Company 1 BECTON DRIVE MC237 Franklin Lakes, NJ 07417 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-04-30 |
Decision Date | 2012-05-30 |
Summary: | summary |