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FDA 510(k) Application Details - DEN110016
Device Classification Name
More FDA Info for this Device
510(K) Number
DEN110016
Device Name
PERCUTANEOUS SURGICAL SET WITH 5MM OR 10MM ATTACHMENTS
Applicant
ETHICON ENDO-SURGERY
4545 CREEK RD.
CINCINNATI, OH 45242 US
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Contact
THOMAS BOSTICCO
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OXT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/21/2011
Decision Date
04/30/2012
Decision
DENG -
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type
Post-NSE
Reviewed By Third Party
N
Expedited Review
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