FDA 510(k) Application Details - K990154

Device Classification Name Camera, Television, Endoscopic, Without Audio

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510(K) Number K990154
Device Name Camera, Television, Endoscopic, Without Audio
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 878.4160

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Classification Product Code FWF
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Date Received 01/19/1999
Decision Date 06/01/1999
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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