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FDA 510(k) Application Details - K052551
Device Classification Name
Syringe, Piston
More FDA Info for this Device
510(K) Number
K052551
Device Name
Syringe, Piston
Applicant
DEVON SAFETY PRODUCTS, INC.
1100 FIRST AVE., SUITE 100
KING OF PRUSSIA, PA 19406 US
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Contact
BARRY L BERLER
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
09/16/2005
Decision Date
09/30/2005
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
Y
Expedited Review
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