FDA 510(k) Application Details - K001362

Device Classification Name Laryngoscope, Endoscope

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510(K) Number K001362
Device Name Laryngoscope, Endoscope
Applicant KARL STORZ IMAGING, INC.
175 CREMONA DR.
GOLETA, CA 93117 US
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Contact TERRY FERNANDEZ
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Regulation Number 876.1500

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Classification Product Code GCI
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Date Received 04/28/2000
Decision Date 07/17/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
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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