The following data is part of a premarket notification filed by B. Braun Medical Inc with the FDA for Perifix And Contiplex Catheter.
Device ID | K153297 |
510k Number | K153297 |
Device Name: | Perifix And Contiplex Catheter |
Classification | Catheter, Conduction, Anesthetic |
Applicant | B. BRAUN MEDICAL INC 901 MARCON BLVD. Allentown, PA 18109 |
Contact | Lisa Giaquinto |
Correspondent | Lisa Giaquinto B. BRAUN MEDICAL INC 901 MARCON BLVD. Allentown, PA 18109 |
Product Code | BSO |
CFR Regulation Number | 868.5120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-11-13 |
Decision Date | 2016-08-12 |
Summary: | summary |