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FDA 510(k) Application Details - K981089
Device Classification Name
Syringe, Piston
More FDA Info for this Device
510(K) Number
K981089
Device Name
Syringe, Piston
Applicant
BAXTER HEALTHCARE CORP.
550 NORTH BRAND BLVD.
GLENDALE, CA 91023 US
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Contact
ANGELA BLACKSHERE
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
03/25/1998
Decision Date
07/05/2000
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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