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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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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