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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biomicroscope, Slit-Lamp, Ac-Powered
510(k) Number K082031
Device Name APPASAMY SLIT LAMP, A1A-11 AND A1A-12 SERIES
Applicant
Appasamy Associates
20, Sbi Officers Colony
1st St.
Arumbakkam, Chennai,  IN 600 106
Applicant Contact R.N. KASTHURI
Correspondent
Underwriters Laboratories, Inc.
333 Pfingsten Rd.
Northbrook,  IL  60062
Correspondent Contact NED DEVINE
Regulation Number886.1850
Classification Product Code
HJO  
Date Received07/17/2008
Decision Date 07/31/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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