FDA 510(k) Application Details - K112548

Device Classification Name Arthroscope

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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
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Regulation Number 888.1100

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Classification Product Code HRX
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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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