FDA 510(k) Application Details - K030009

Device Classification Name Arthroscope

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510(K) Number K030009
Device Name Arthroscope
Applicant KARL STORZ ENDOSCOPY
600 CORPORATE POINTE
CULVER CITY, CA 90230-7600 US
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Contact RENATE A MACLAREN
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 01/02/2003
Decision Date 04/02/2003
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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