The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Injekt Syringe.
| Device ID | K063280 |
| 510k Number | K063280 |
| Device Name: | INJEKT SYRINGE |
| Classification | Syringe, Piston |
| Applicant | B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown, PA 18109 -9341 |
| Contact | Christine Ford |
| Correspondent | Christine Ford B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown, PA 18109 -9341 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-31 |
| Decision Date | 2006-11-17 |
| Summary: | summary |