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FDA 510(k) Application Details - K112548
Device Classification Name
Arthroscope
More FDA Info for this Device
510(K) Number
K112548
Device Name
Arthroscope
Applicant
ALTOMEC ENDOSCOPY INC
7305 HANCOCK VILLAGE DR.
SUITE 109
CHESTERFIELD, VA 23832 US
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Contact
DARREN REEVES
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
09/01/2011
Decision Date
08/15/2012
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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