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FDA 510(k) Application Details - K083471
Device Classification Name
More FDA Info for this Device
510(K) Number
K083471
Device Name
GMD UNIVERSAL SLING, MODEL PRODUCT CODE 1010 AND 1020
Applicant
GENERIC MEDICAL DEVICE, INC.
5727 BAKER WAY NW STE 201
GIG HARBOR, WA 98332 US
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Contact
MONICA MONTANEZ
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Regulation Number
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Classification Product Code
OTN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/24/2008
Decision Date
03/03/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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