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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Spectacle, Non-Custom (Prescription)
510(k) Number K853110
Device Name SPECTACLE PRESCRIPTION LENSES
Applicant
Ancie Laboratories
5200 J. Philadelphia Way
Lanham,  MD  20706
Applicant Contact RON ACE
Correspondent
Ancie Laboratories
5200 J. Philadelphia Way
Lanham,  MD  20706
Correspondent Contact RON ACE
Regulation Number886.5844
Classification Product Code
HQG  
Date Received07/24/1985
Decision Date 08/09/1985
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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