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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 K142837
Device Name HEINE SIGMA 250 & HEINE SIGMA 250 M2
Applicant
HEINE Optotechnik GmbH & Co. KG
Kientalstr. 7
Herrsching,  DE 82211
Applicant Contact Bettina Seim
Correspondent
HEINE Optotechnik GmbH & Co. KG
Kientalstr. 7
Herrsching,  DE 82211
Correspondent Contact Bettina Seim
Regulation Number886.1570
Classification Product Code
HLJ  
Date Received09/30/2014
Decision Date 01/29/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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