FDA 510(k) Application Details - K161723

Device Classification Name

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510(K) Number K161723
Device Name ulrich Transfer Set
Applicant ulrich GmbH & Co. KG
Buchbrunnenweg 12
Ulm 89081 DE
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Contact Sven Erdmann
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Regulation Number

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Classification Product Code PQH
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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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