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FDA 510(k) Application Details - K082865
Device Classification Name
Dressing,Wound,Hydrogel W/Out Drug And/Or Biologic
More FDA Info for this Device
510(K) Number
K082865
Device Name
Dressing,Wound,Hydrogel W/Out Drug And/Or Biologic
Applicant
GORBEC PHARMACEUTICAL SERVICES, INC.
2445 SOUTH ALSTON AVENUE
DURHAM, NC 27713 US
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Contact
SANDRA R KIRCUS
Other 510(k) Applications for this Contact
Regulation Number
878.4022
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Classification Product Code
NAE
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More FDA Info for this Product Code
Date Received
09/29/2008
Decision Date
10/23/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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