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FDA 510(k) Application Details - K193028
Device Classification Name
Injector And Syringe, Angiographic
More FDA Info for this Device
510(K) Number
K193028
Device Name
Injector And Syringe, Angiographic
Applicant
Bayer Medical Care Inc.
1 Bayer Drive
Indianola, PA 15051 US
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Contact
Kelly Frank
Other 510(k) Applications for this Contact
Regulation Number
870.1650
More FDA Info for this Regulation Number
Classification Product Code
DXT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/30/2019
Decision Date
12/05/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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