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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ophthalmoscope, ac-powered
510(k) Number K110205
Device Name AAIO-7, AAIO WIRLESS
Applicant
APPASAMY ASSOCIATES
20, SBI OFFICERS COLONY
1ST STREET
ARUMBAKKAM, CHENNAI,  IN 600 106
Applicant Contact K RENGASAMY
Correspondent
UNDERWRITERS LABORATORIES, INC.
2600 NW LAKE RD.
CAMAS,  WA  98607 -9526
Correspondent Contact MARC M MOUSER
Regulation Number886.1570
Classification Product Code
HLI  
Subsequent Product Code
HLJ  
Date Received01/25/2011
Decision Date 02/09/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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