FDA 510(k) Application Details - K983384

Device Classification Name Arthroscope

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510(K) Number K983384
Device Name Arthroscope
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC.
600 CORPORATE POINTE
CULVER CITY, CA 90230-7600 US
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Contact KEVIN KENNAN
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 09/25/1998
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 Traditional
Reviewed By Third Party N
Expedited Review



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