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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Orbital, Extra-Ocular
510(k) Number K902308
Device Name TAMCENAN OCULAR EXPLANTS AND BANDS
Applicant
Tamcenan Corp.
1703 S. Minnesota Ave.
Sioux Falls,  SD  57105
Applicant Contact THOMAS C WHITE
Correspondent
Tamcenan Corp.
1703 S. Minnesota Ave.
Sioux Falls,  SD  57105
Correspondent Contact THOMAS C WHITE
Regulation Number886.3340
Classification Product Code
HQX  
Date Received05/22/1990
Decision Date 06/19/1990
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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