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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 K852126
Device Name ATF 101 TRAIL FRAME
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 Received05/15/1985
Decision Date 06/05/1985
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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