The following data is part of a premarket notification filed by B. Braun Instruments with the FDA for Extension Sets.
Device ID | K760385 |
510k Number | K760385 |
Device Name: | EXTENSION SETS |
Classification | Accessories, Catheter |
Applicant | B. BRAUN INSTRUMENTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KGZ |
CFR Regulation Number | 878.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-08-05 |
Decision Date | 1976-11-02 |