The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Contiplex C Continuous Peripheral Nerve Block Needle.
Device ID | K121846 |
510k Number | K121846 |
Device Name: | CONTIPLEX C CONTINUOUS PERIPHERAL NERVE BLOCK NEEDLE |
Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
Applicant | B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown, PA 18109 -9341 |
Contact | Nancy Skocypec |
Correspondent | Nancy Skocypec 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 | 2012-06-25 |
Decision Date | 2012-11-20 |
Summary: | summary |