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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Projector, Ophthalmic
510(k) Number K921214
Device Name OPHTHALMIC PROJECTOR
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 Number886.1680
Classification Product Code
HOS  
Date Received03/13/1992
Decision Date 06/11/1992
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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