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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Ophthalmic, Ac-Powered
510(k) Number K980295
Device Name OPHTHAVISION IMAGING SYSTEM
Applicant
Mrp Group, Inc.
1111 W. Lowell Ave.
Haverhill,  MA  01832
Applicant Contact MATTHEW CARNEVALE
Correspondent
Mrp Group, Inc.
1111 W. Lowell Ave.
Haverhill,  MA  01832
Correspondent Contact MATTHEW CARNEVALE
Regulation Number886.1120
Classification Product Code
HKI  
Date Received01/27/1998
Decision Date 05/19/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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