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FDA 510(k) Application Details - K082293
Device Classification Name
Arthroscope
More FDA Info for this Device
510(K) Number
K082293
Device Name
Arthroscope
Applicant
BIOVISION TECHNOLOGIES, LLC
221 CORPORATE CIRCLE
SUITE H
GOLDEN, CO 80401 US
Other 510(k) Applications for this Company
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
08/12/2008
Decision Date
09/09/2008
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
Y
Expedited Review
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