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FDA 510(k) Application Details - K981174
Device Classification Name
Plasma, Coagulation Factor Deficient
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510(K) Number
K981174
Device Name
Plasma, Coagulation Factor Deficient
Applicant
PRECISION BIOLOGICALS, INC.
900 WINDMILL ROAD
UNIT 100
DARTMOUTH, NOVA SCOTIA B3B 1P7 CA
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Contact
SANDY MORRISON
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Regulation Number
864.7290
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Classification Product Code
GJT
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More FDA Info for this Product Code
Date Received
04/01/1998
Decision Date
01/13/1999
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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