FDA 510(k) Application Details - K193010

Device Classification Name

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510(K) Number K193010
Device Name Liebel-Flarsheim IBP Transfer Set
Applicant Liebel-Flarsheim Company LLC
1034 South Brentwood Blvd, Suite 800
Richmond Heights, MO 63117 US
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Contact Alice Lorenzo
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Regulation Number

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Classification Product Code PQH
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Date Received 10/29/2019
Decision Date 11/18/2020
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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