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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, lens, trial, ophthalmic
510(k) Number K852056
Device Name ACC CROSS CYLINDERS
Applicant
ASCON MEDICAL INSTRUMENTS, LTD.
825 N. CASS AVE., SUITE 208
WESTMONT,  IL  60559
Applicant Contact NALLA KRISHNAN
Correspondent
ASCON MEDICAL INSTRUMENTS, LTD.
825 N. CASS AVE., SUITE 208
WESTMONT,  IL  60559
Correspondent Contact NALLA KRISHNAN
Regulation Number886.1405
Classification Product Code
HPC  
Date Received05/09/1985
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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