FDA 510(k) Application Details - K983910

Device Classification Name Arthroscope

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510(K) Number K983910
Device Name Arthroscope
Applicant W.O.M. WORLD OF MEDICINE, GMBH
194 BRANCH ST.
MANSFIELD, MA 02048 US
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Contact MICHAEL MCGRAIL
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 11/03/1998
Decision Date 11/25/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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