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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stand, instrument, ac-powered, ophthalmic
510(k) Number K913961
Device Name OPHTHALMIC STAND
Applicant
LUNEAU OPHTALMOLOGIE SA
B.P. 252
CHARTRES, CEDEX,  FR 28005
Applicant Contact YOUNG
Correspondent
LUNEAU OPHTALMOLOGIE SA
B.P. 252
CHARTRES, CEDEX,  FR 28005
Correspondent Contact YOUNG
Regulation Number886.1860
Classification Product Code
HMF  
Date Received09/05/1991
Decision Date 12/04/1991
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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