FDA 510(k) Application Details - K070874

Device Classification Name Arthroscope

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510(K) Number K070874
Device Name Arthroscope
Applicant ARTHRO KINETICS INC.
8 FANEUIL HALL, 3RD FLOOR
BOSTON, MA 02109 US
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Contact JAMES HOBBS
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 03/29/2007
Decision Date 11/02/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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