The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Contiplex Stim Continuous Nerve Block Set.
Device ID | K063282 |
510k Number | K063282 |
Device Name: | CONTIPLEX STIM CONTINUOUS NERVE BLOCK SET |
Classification | Anesthesia Conduction Kit |
Applicant | B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown, PA 18109 -9341 |
Contact | Rebecca Stolarick |
Correspondent | Rebecca Stolarick 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 | 2006-10-31 |
Decision Date | 2007-06-20 |
Summary: | summary |