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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 K062763
Device Name NONCON ROBO PACHY F&A
Applicant
Konan Medical, Inc.
377 Route 17s
Hasbrouck Heights,  NJ  07604
Applicant Contact GEORGE MYERS
Correspondent
Konan Medical, Inc.
377 Route 17s
Hasbrouck Heights,  NJ  07604
Correspondent Contact GEORGE MYERS
Regulation Number886.1850
Classification Product Code
NQE  
Date Received09/15/2006
Decision Date 02/22/2008
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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