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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Microscope, Specular
510(k) Number K120264
Device Name KONAN SPECULAR MICROSCOPE XIV
Applicant
Konan Medical, Inc.
2976 Calle Gaucho
San Clemente,  CA  92673
Applicant Contact DAVID S FERNQUIST
Correspondent
Konan Medical, Inc.
2976 Calle Gaucho
San Clemente,  CA  92673
Correspondent Contact DAVID S FERNQUIST
Regulation Number886.1850
Classification Product Code
NQE  
Date Received01/30/2012
Decision Date 04/11/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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