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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 K040325
Device Name PANORET, MODEL PNM 60
Applicant
Medibell Medical Vision Technologies , Ltd.
Matam Hight Technologies Ctr
Haifa,  IL 31905
Applicant Contact DAN LAOR
Correspondent
Medibell Medical Vision Technologies , Ltd.
Matam Hight Technologies Ctr
Haifa,  IL 31905
Correspondent Contact DAN LAOR
Regulation Number886.1120
Classification Product Code
HKI  
Date Received02/10/2004
Decision Date 03/08/2004
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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