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FDA 510(k) Application Details - K101534
Device Classification Name
Electrosurgical, Cutting & Coagulation & Accessories
More FDA Info for this Device
510(K) Number
K101534
Device Name
CONMED ALTRUS THERMAL TISSUE FUSION SYSTEM
Applicant
CONMED CORP.
14603 E. FREMONT AVE.
CENTENNIAL, CO 80112
Other 510(k) Applications for this Company
More Company Info and Competitors
Contact
SHAWN REIDEL
Other 510(k) Applications for this Contact
Regulation Number
878.4400
More FDA Info for this Regulation Number
Classification Product Code
GEI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/03/2010
Decision Date
11/24/2010
Decision
SE - Substantially Equivalent
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
Y
Expedited Review
N
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