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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name sponge, ophthalmic
510(k) Number K852055
Device Name ASCON OPHTHALMIC SPONGE
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 Number886.4790
Classification Product Code
HOZ  
Date Received05/09/1985
Decision Date 09/04/1985
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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