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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 K001768
Device Name OCCU-FLO PUNCTUM PLUGS
Applicant
U.S. Iol, Inc.
2500 Sandersville Rd.
Lexington,  KY  40511
Applicant Contact TERESA BURTON
Correspondent
U.S. Iol, Inc.
2500 Sandersville Rd.
Lexington,  KY  40511
Correspondent Contact TERESA BURTON
Classification Product Code
LZU  
Date Received06/12/2000
Decision Date 09/19/2000
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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