FDA 510(k) Application Details - K051505

Device Classification Name Light, Surgical, Accessories

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510(K) Number K051505
Device Name Light, Surgical, Accessories
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC.
600 CORPORATE POINTE
CULVER CITY, CA 90230-7600 US
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Contact PAUL S LEE
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Regulation Number 878.4580

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Classification Product Code FTA
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Date Received 06/07/2005
Decision Date 08/11/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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