The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Addease 20mm Binary Connector With 17 Ga. Needle.
| Device ID | K090905 |
| 510k Number | K090905 |
| Device Name: | ADDEASE 20MM BINARY CONNECTOR WITH 17 GA. NEEDLE |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown, PA 18109 -9341 |
| Contact | Angela J Caravella |
| Correspondent | Angela J Caravella B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown, PA 18109 -9341 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-01 |
| Decision Date | 2009-04-27 |
| Summary: | summary |