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FDA 510(k) Application Details - K053267
Device Classification Name
Arthroscope
More FDA Info for this Device
510(K) Number
K053267
Device Name
Arthroscope
Applicant
ENDIUS, INC.
23 WEST BACON ST.
PLAINVILLE, MA 02762 US
Other 510(k) Applications for this Company
Contact
CHRISTINE KUNTZ-NASSIF
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
11/23/2005
Decision Date
01/13/2006
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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