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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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