The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Contiplex D Continuous Nerve Block Set, Model 331687, 331686, 331685, 331680.
| Device ID | K100241 |
| 510k Number | K100241 |
| Device Name: | CONTIPLEX D CONTINUOUS NERVE BLOCK SET, MODEL 331687, 331686, 331685, 331680 |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| 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 | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-27 |
| Decision Date | 2010-04-16 |
| Summary: | summary |