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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Frame, Trial, Ophthalmic
510(k) Number K852548
Device Name ATL 225 MW TRAIL LENS SET
Applicant
Ascon Medical Instruments, Ltd.
825 N. Cass Ave., Suite 208
Westmont,  IL  60559
Applicant Contact RAVI NALLAKRISHNAN
Correspondent
Ascon Medical Instruments, Ltd.
825 N. Cass Ave., Suite 208
Westmont,  IL  60559
Correspondent Contact RAVI NALLAKRISHNAN
Regulation Number886.1415
Classification Product Code
HPA  
Date Received06/12/1985
Decision Date 07/31/1985
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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