The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Contiplex Fx.
| Device ID | K113059 |
| 510k Number | K113059 |
| Device Name: | CONTIPLEX FX |
| Classification | Anesthesia Conduction Kit |
| Applicant | B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown, PA 18109 -9341 |
| Contact | Lisa Giaquinto |
| Correspondent | Lisa Giaquinto B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown, PA 18109 -9341 |
| Product Code | CAZ |
| CFR Regulation Number | 868.5140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-14 |
| Decision Date | 2012-01-24 |
| Summary: | summary |