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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 K890919
Device Name TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT
Applicant
Eagle Vision, Inc.
4903 Sangamore Rd.
Bethesda,  MD  20816
Applicant Contact L MACKEEN,PHD
Correspondent
Eagle Vision, Inc.
4903 Sangamore Rd.
Bethesda,  MD  20816
Correspondent Contact L MACKEEN,PHD
Classification Product Code
LZU  
Date Received02/23/1989
Decision Date 05/16/1989
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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