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FDA 510(k) Application Details - K161723
Device Classification Name
More FDA Info for this Device
510(K) Number
K161723
Device Name
ulrich Transfer Set
Applicant
ulrich GmbH & Co. KG
Buchbrunnenweg 12
Ulm 89081 DE
Other 510(k) Applications for this Company
Contact
Sven Erdmann
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PQH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/22/2016
Decision Date
12/21/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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