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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name ophthalmoscope, battery-powered
510(k) Number K070270
Device Name PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36
Applicant
KIRCHNER & WILHELM GMBH + CO.KG
55 NORTHERN BLVD, SUITE 200
GREAT NECK,  NY  11021
Applicant Contact NATALYA VALERIO
Correspondent
KIRCHNER & WILHELM GMBH + CO.KG
55 NORTHERN BLVD, SUITE 200
GREAT NECK,  NY  11021
Correspondent Contact NATALYA VALERIO
Regulation Number886.1570
Classification Product Code
HLJ  
Date Received01/29/2007
Decision Date 11/05/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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