The following data is part of a premarket notification filed by Hospira, Inc. with the FDA for Symbiq Infusion And Adminstration Set.
Device ID | K110901 |
510k Number | K110901 |
Device Name: | SYMBIQ INFUSION AND ADMINSTRATION SET |
Classification | Pump, Infusion |
Applicant | HOSPIRA, INC. 275 NORTH FIELD DR. Lake Forest, IL 60045 |
Contact | Ray Silkaitis |
Correspondent | Ray Silkaitis HOSPIRA, INC. 275 NORTH FIELD DR. Lake Forest, IL 60045 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-03-31 |
Decision Date | 2012-03-05 |
Summary: | summary |