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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Ophthalmic
510(k) Number K901618
Device Name OCULAR INFUSION CANNULA SYSTEM
Applicant
TAMCENAN CORP.
1703 SOUTH MINNESOTA AVE.
SIOUX FALLS,  SD  57105
Applicant Contact C WHITE
Correspondent
TAMCENAN CORP.
1703 SOUTH MINNESOTA AVE.
SIOUX FALLS,  SD  57105
Correspondent Contact C WHITE
Regulation Number886.4350
Classification Product Code
HMX  
Date Received04/06/1990
Decision Date 05/31/1990
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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