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FDA 510(k) Application Details - K180937
Device Classification Name
Syringe, Piston
More FDA Info for this Device
510(K) Number
K180937
Device Name
Syringe, Piston
Applicant
Surgentec, LLC
7601 N Federal Hwy #150A
Boca Raton, FL 33487 US
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Contact
Boca Raton
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Regulation Number
880.5860
More FDA Info for this Regulation Number
Classification Product Code
FMF
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More FDA Info for this Product Code
Date Received
04/10/2018
Decision Date
05/10/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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