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FDA 510(k) Application Details - K080648
Device Classification Name
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510(K) Number
K080648
Device Name
TRAUMASTAT RAPID HEMOSTATIC WOUND DRESSING BANDAGE
Applicant
ORE-MEDIX, LLC
7651 S. 700 WEST, SUITE 105
MIDVALE, UT 84047 US
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Contact
DONALD F GRABARZ
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Regulation Number
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Classification Product Code
QSY
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Date Received
03/07/2008
Decision Date
05/07/2008
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
Y
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