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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name lens, fundus, hruby, diagnostic
510(k) Number K802927
Device Name SEBESTYEN IRRIGATING CONTACT LENS
Applicant
COOPER MEDICAL DEVICES CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
COOPER MEDICAL DEVICES CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number886.1395
Classification Product Code
HJI  
Date Received11/19/1980
Decision Date 02/05/1981
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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