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FDA 510(k) Application Details - K162057
Device Classification Name
Syringe, Piston
More FDA Info for this Device
510(K) Number
K162057
Device Name
Syringe, Piston
Applicant
ConceptoMed AS
Hattvikveien 2
Ballstad N-8373 NO
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Contact
Marit Martinsen
Other 510(k) Applications for this Contact
Regulation Number
880.5860
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Classification Product Code
FMF
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More FDA Info for this Product Code
Date Received
07/26/2016
Decision Date
01/11/2017
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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