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FDA 510(k) Application Details - K171191
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K171191
Device Name
Dressing, Wound, Drug
Applicant
Global Health Solutions, LLC
1360 Redmond Circle
Rome, GA 30165 US
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Contact
Bradley Burnam
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
FRO
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More FDA Info for this Product Code
Date Received
04/24/2017
Decision Date
08/25/2017
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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