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FDA 510(k) Application Details - K043602
Device Classification Name
Retractor
More FDA Info for this Device
510(K) Number
K043602
Device Name
Retractor
Applicant
MEDTRONIC SOFAMOR DANEK
1800 PYRAMID PLACE
MEMPHIS, TN 38132 US
Other 510(k) Applications for this Company
Contact
RICHARD TREHARNE
Other 510(k) Applications for this Contact
Regulation Number
878.4800
More FDA Info for this Regulation Number
Classification Product Code
GAD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/29/2004
Decision Date
02/23/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
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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