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FDA 510(k) Application Details - K170675
Device Classification Name
Syringe, Piston
More FDA Info for this Device
510(K) Number
K170675
Device Name
Syringe, Piston
Applicant
Surgentec, LLC
7601 N Federal Highway # 150B
Boca Raton, FL 33487 US
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Contact
Travis Greenhalgh
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
03/06/2017
Decision Date
07/19/2017
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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