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FDA 510(k) Application Details - K963333
Device Classification Name
Camera, Ophthalmic, Ac-Powered
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510(K) Number
K963333
Device Name
Camera, Ophthalmic, Ac-Powered
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
886.1120
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Classification Product Code
HKI
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More FDA Info for this Product Code
Date Received
08/23/1996
Decision Date
10/22/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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