FDA 510(k) Application Details - K023187

Device Classification Name Arthroscope

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510(K) Number K023187
Device Name Arthroscope
Applicant KARL STORZ ENDOSCOPY
600 CORPORATE POINTE
CULVER CITY, CA 90230-7600 US
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Contact JAMES A LEE
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 09/24/2002
Decision Date 12/02/2002
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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