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FDA 510(k) Application Details - K083552
Device Classification Name
Arthroscope
More FDA Info for this Device
510(K) Number
K083552
Device Name
Arthroscope
Applicant
HOOGLAND SPINE PRODUCTS GMBH
ARABELLASTR 4
MUENCHEN D-81925 DE
Other 510(k) Applications for this Company
Contact
BORIS MIKLITZ
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
12/01/2008
Decision Date
10/09/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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