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FDA 510(k) Application Details - K984131
Device Classification Name
Control, Plasma, Abnormal
More FDA Info for this Device
510(K) Number
K984131
Device Name
Control, Plasma, Abnormal
Applicant
PACIFIC HEMOSTASIS
11515 VANSTORY DR.
HUNTERSVILLE, NC 28078-8144 US
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Contact
MARK ELLIS
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Regulation Number
864.5425
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Classification Product Code
GGC
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More FDA Info for this Product Code
Date Received
11/18/1998
Decision Date
12/01/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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