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FDA 510(k) Application Details - K101864
Device Classification Name
Arthroscope
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510(K) Number
K101864
Device Name
Arthroscope
Applicant
Medtronic
1221 CROSSMAN AVE.
SUNNYVALE, CA 94089 US
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Contact
HEINZ STENEBERG
Other 510(k) Applications for this Contact
Regulation Number
888.1100
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Classification Product Code
HRX
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More FDA Info for this Product Code
Date Received
07/02/2010
Decision Date
10/14/2010
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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