The following data is part of a premarket notification filed by B. Braun Medical Inc. with the FDA for Lockbox For Perfusor Space Pca Infusion Pump.
Device ID | K173531 |
510k Number | K173531 |
Device Name: | Lockbox For Perfusor Space PCA Infusion Pump |
Classification | Accessories, Pump, Infusion |
Applicant | B. Braun Medical Inc. 901 Marcon Blvd Allentown, PA 18109 |
Contact | Tracy Maddock |
Correspondent | Tracy Maddock B. Braun Medical Inc. 901 Marcon Blvd Allentown, PA 18109 |
Product Code | MRZ |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-11-15 |
Decision Date | 2018-08-02 |