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FDA 510(k) Application Details - K022578
Device Classification Name
Arthroscope
More FDA Info for this Device
510(K) Number
K022578
Device Name
Arthroscope
Applicant
ENDIUS, INC.
23 WEST BACON ST.
PLAINVILLE, MA 02762 US
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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
08/05/2002
Decision Date
08/23/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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