The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for B. Braun Piston Syringes And Omnican And Omnifix Insulin Syringes.
| Device ID | K071459 |
| 510k Number | K071459 |
| Device Name: | B. BRAUN PISTON SYRINGES AND OMNICAN AND OMNIFIX INSULIN SYRINGES |
| 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 | 2007-05-25 |
| Decision Date | 2007-08-16 |
| Summary: | summary |