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FDA 510(k) Application Details - K050580
Device Classification Name
Arthroscope
More FDA Info for this Device
510(K) Number
K050580
Device Name
Arthroscope
Applicant
SMITH & NEPHEW ENDOSCOPY, INC.
150 Minuteman Road
Andover, MA 01810 US
Other 510(k) Applications for this Company
Contact
KATHLEEN BURNS
Other 510(k) Applications for this Contact
Regulation Number
888.1100
More FDA Info for this Regulation Number
Classification Product Code
HRX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/07/2005
Decision Date
04/20/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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