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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biomicroscope, Slit-Lamp, Ac-Powered
510(k) Number K945445
Device Name BOBES SLIT LAMP
Applicant
Bobes S.A.
Ctra. Fuente Del Toro, S/N
28710 El Molar
Madrid,  ES
Applicant Contact FRANCISCO J BOBES NAVES
Correspondent
Bobes S.A.
Ctra. Fuente Del Toro, S/N
28710 El Molar
Madrid,  ES
Correspondent Contact FRANCISCO J BOBES NAVES
Regulation Number886.1850
Classification Product Code
HJO  
Date Received11/07/1994
Decision Date 10/17/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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