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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name ophthalmoscope, ac-powered
510(k) Number K871268
Device Name RODENSTOCK SCANNING LASER OPHTHALMOSCOPE
Applicant
G. RODENSTOCK INSTRUMENTE GMBH
drachenseestrabe 10-12
postfach 701560, d-8000
munchen 70, west germany,  DE
Applicant Contact klingbeil
Correspondent
G. RODENSTOCK INSTRUMENTE GMBH
drachenseestrabe 10-12
postfach 701560, d-8000
munchen 70, west germany,  DE
Correspondent Contact klingbeil
Regulation Number886.1570
Classification Product Code
HLI  
Date Received03/31/1987
Decision Date 06/10/1987
Decision substantially equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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