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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ophthalmoscope, Laser, Scanning
510(k) Number K072259
Device Name OPHTHALMOSCOPE F-10
Applicant
Nidek Co., Ltd.
1733 Canton Lane
Marietta,  GA  30062
Applicant Contact PAUL SUMNER
Correspondent
Nidek Co., Ltd.
1733 Canton Lane
Marietta,  GA  30062
Correspondent Contact PAUL SUMNER
Regulation Number886.1570
Classification Product Code
MYC  
Date Received08/14/2007
Decision Date 05/06/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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