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FDA 510(k) Application Details - K081729
Device Classification Name
Generator, Lesion, Radiofrequency
More FDA Info for this Device
510(K) Number
K081729
Device Name
Generator, Lesion, Radiofrequency
Applicant
BIOFORM MEDICAL, INC.
4133 COURTNEY ROAD, #10
FRANKSVILLE, WI 53126 US
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Contact
LORI HAYS
Other 510(k) Applications for this Contact
Regulation Number
882.4400
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Classification Product Code
GXD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/18/2008
Decision Date
08/07/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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