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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plug, Scleral
510(k) Number K990872
Device Name SCLERAL PLUGS, 19 AND 20 GAUGE
Applicant
Ophthalmic Consultants, Inc.
65 N. Main, Suite 101
P.O. Box 154
Tooele,  UT  84074
Applicant Contact JOHN E LINCOLN
Correspondent
Ophthalmic Consultants, Inc.
65 N. Main, Suite 101
P.O. Box 154
Tooele,  UT  84074
Correspondent Contact JOHN E LINCOLN
Regulation Number886.4155
Classification Product Code
LXP  
Date Received03/16/1999
Decision Date 07/13/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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