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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Forceps, Ophthalmic
510(k) Number K852057
Device Name ASCON SURGICAL INSTRUMENTS
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 Number886.4350
Classification Product Code
HNR  
Date Received05/09/1985
Decision Date 06/27/1985
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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