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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 K844362
Device Name OPHTHALMIC CHAIR
Applicant
Luneau Laboratories
2000 L. St. NW
Suite 715
Washington,  DC  20036
Applicant Contact CHAMBORD
Correspondent
Luneau Laboratories
2000 L. St. NW
Suite 715
Washington,  DC  20036
Correspondent Contact CHAMBORD
Regulation Number886.1860
Classification Product Code
HMF  
Date Received11/13/1984
Decision Date 12/11/1984
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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