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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 K953030
Device Name SLIT LAMP AIA 11
Applicant
Naveen Intl., Inc.
193 Rock Ridge Rd.
Millersville,  MD  21108
Applicant Contact SRINI V SRINIVASAN
Correspondent
Naveen Intl., Inc.
193 Rock Ridge Rd.
Millersville,  MD  21108
Correspondent Contact SRINI V SRINIVASAN
Regulation Number886.1850
Classification Product Code
HJO  
Date Received06/29/1995
Decision Date 07/12/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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