FDA 510(k) Application Details - K010785

Device Classification Name Clamp, Vascular

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510(K) Number K010785
Device Name Clamp, Vascular
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC.
600 CORPORATE POINTE
CULVER CITY, CA 90230-7600 US
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Contact JAMES A LEE
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Regulation Number 870.4450

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Classification Product Code DXC
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Date Received 03/15/2001
Decision Date 08/21/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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