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FDA 510(k) Application Details - K190604
Device Classification Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
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510(K) Number
K190604
Device Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Applicant
Velano Vascular
221 Pine St #200
San Francisco, CA 94104 US
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Contact
Tiffini Wittwer
Other 510(k) Applications for this Contact
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
03/08/2019
Decision Date
05/13/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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