The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for One.click Needle.
| Device ID | K033575 |
| 510k Number | K033575 |
| Device Name: | ONE.CLICK NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown, PA 18109 -9341 |
| Contact | Jennifer A Kosoy |
| Correspondent | Jennifer A Kosoy B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown, PA 18109 -9341 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-12 |
| Decision Date | 2004-02-09 |
| Summary: | summary |