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FDA 510(k) Application Details - K000438
Device Classification Name
Syringe, Piston
More FDA Info for this Device
510(K) Number
K000438
Device Name
Syringe, Piston
Applicant
BIOSURGICAL CORP.
5990 STONERIDGE AVE.,
SUITE 112
PLEASANTON, CA 94566 US
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Contact
TERRY LAAS
Other 510(k) Applications for this Contact
Regulation Number
880.5860
More FDA Info for this Regulation Number
Classification Product Code
FMF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/10/2000
Decision Date
05/03/2000
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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