FDA 510(k) Application Details - K003831

Device Classification Name Arthroscope

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510(K) Number K003831
Device Name Arthroscope
Applicant GLOBAL ENDOSCOPY, INC.
914 W. ESTES CT.
SCHAUMBURG, IL 60193-4426 US
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Contact NICK MIRCEA
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 12/11/2000
Decision Date 07/20/2001
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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