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FDA 510(k) Application Details - K980078
Device Classification Name
Syringe, Piston
More FDA Info for this Device
510(K) Number
K980078
Device Name
Syringe, Piston
Applicant
P.T. PANCA PUSAKA DELI
185 LAROE RD.
CHESTER, NY 10918 US
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Contact
JANE CAMPBELL
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
01/08/1998
Decision Date
10/16/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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