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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 K102492
Device Name P200MAAF
Applicant
Optos Plc.
555 Thirteenth St. NW
Columbia Square
Washington,  DC  20004 -1109
Applicant Contact HOWARD M HOLSTEIN
Correspondent
Optos Plc.
555 Thirteenth St. NW
Columbia Square
Washington,  DC  20004 -1109
Correspondent Contact HOWARD M HOLSTEIN
Regulation Number886.1570
Classification Product Code
MYC  
Date Received08/31/2010
Decision Date 09/30/2010
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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