FDA 510(k) Application Details - K122662

Device Classification Name Arthroscope

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510(K) Number K122662
Device Name Arthroscope
Applicant VERTIFLEX, INC.
1351 Calle Avanzado
San Clemente, CA 92673 US
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Contact STEVE REITZLER
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 08/31/2012
Decision Date 11/13/2012
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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