The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for A6 Luer Access Device.
| Device ID | K083723 |
| 510k Number | K083723 |
| Device Name: | A6 LUER ACCESS DEVICE |
| Classification | Set, Administration, Intravascular |
| Applicant | B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown, PA 18109 -9341 |
| Contact | Bonnie J Kincaid, Rac |
| Correspondent | Bonnie J Kincaid, Rac B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown, PA 18109 -9341 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-15 |
| Decision Date | 2009-06-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40616258022633 | K083723 | 000 |