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FDA 510(k) Application Details - K120958
Device Classification Name
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510(K) Number
K120958
Device Name
POSISEP AND POSISEP X HEMOSTAT DRESSINGS
Applicant
HEMOSTASIS, LLC
5000 Township Pkwy
Saint Paul, MN 55110 US
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Contact
BERNARD HORWATH
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Regulation Number
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Classification Product Code
QSY
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Date Received
03/30/2012
Decision Date
07/25/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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