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FDA 510(k) Application Details - K080617
Device Classification Name
Arthroscope
More FDA Info for this Device
510(K) Number
K080617
Device Name
Arthroscope
Applicant
RICHARD WOLF MEDICAL INSTRUMENTS CORP.
353 CORPORATE WOODS PKWY.
VERNON HILLS, IL 60061 US
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Contact
NIELS SCHMIDT
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
03/04/2008
Decision Date
06/27/2008
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
N
Expedited Review
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