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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plug, Punctum
510(k) Number K905750
Device Name LACRIMAL PLUG
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
Classification Product Code
LZU  
Date Received12/24/1990
Decision Date 03/14/1991
Decision Substantially Equivalent (SESE)
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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