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FDA 510(k) Application Details - K022046
Device Classification Name
Plasma, Coagulation Control
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510(K) Number
K022046
Device Name
Plasma, Coagulation Control
Applicant
VITAL SCIENTIFIC N.V.
ONE GATEWAY CENTER SUITE 411
NEWTON, MA 02458 US
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Contact
ISRAEL M STEIN
Other 510(k) Applications for this Contact
Regulation Number
864.5425
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Classification Product Code
GGN
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More FDA Info for this Product Code
Date Received
06/24/2002
Decision Date
07/23/2002
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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