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FDA 510(k) Application Details - K990579
Device Classification Name
Reagent, Russel Viper Venom
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510(K) Number
K990579
Device Name
Reagent, Russel Viper Venom
Applicant
PRECISION BIOLOGIC
900 WINDMILL RD., SUITE 100
DARTMOUTH, N.S. B3B 1P7 CA
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Contact
SANDY MORRISON
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Regulation Number
864.8950
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Classification Product Code
GIR
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More FDA Info for this Product Code
Date Received
02/23/1999
Decision Date
07/23/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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