The following data is part of a premarket notification filed by Cardinal Health, Alaris Products with the FDA for Blood Hand Pump Administration Set.
Device ID | K050115 |
510k Number | K050115 |
Device Name: | BLOOD HAND PUMP ADMINISTRATION SET |
Classification | Set, Blood Transfusion |
Applicant | CARDINAL HEALTH, ALARIS PRODUCTS 10221 WATERIDGE CIRCLE San Diego, CA 92121 -2772 |
Contact | Stacy L Lewis |
Correspondent | Stacy L Lewis CARDINAL HEALTH, ALARIS PRODUCTS 10221 WATERIDGE CIRCLE San Diego, CA 92121 -2772 |
Product Code | BRZ |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-01-18 |
Decision Date | 2005-04-01 |
Summary: | summary |