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FDA 510(k) Application Details - K191313
Device Classification Name
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510(K) Number
K191313
Device Name
Unity Subcutaneous Infusion System for Remodulin
Applicant
DEKA Research & Development
340 Commercial Street
Manchester, NH 03101 US
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Contact
Jason Demers
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Regulation Number
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Classification Product Code
QJY
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Date Received
05/15/2019
Decision Date
02/21/2020
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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