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FDA 510(k) Application Details - K201237
Device Classification Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
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510(K) Number
K201237
Device Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Applicant
VelanoáVascular
221áPineáStreetá#200
SanáFrancisco, CA 94104 US
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Contact
Tiffiniá Wittwer
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Regulation Number
862.1675
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Classification Product Code
JKA
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More FDA Info for this Product Code
Date Received
05/07/2020
Decision Date
10/03/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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