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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, lens, trial, ophthalmic
510(k) Number K945443
Device Name BOBES LENS SET
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 Number886.1405
Classification Product Code
HPC  
Date Received11/07/1994
Decision Date 07/19/1995
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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