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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 K925671
Device Name DISPOSABLE SCLERAL PLUGS
Applicant
O.R. Specialties, Inc.
4749 Appletree Ln.
Tuscaloosa,  AL  35405
Applicant Contact JACK W HOWARD
Correspondent
O.R. Specialties, Inc.
4749 Appletree Ln.
Tuscaloosa,  AL  35405
Correspondent Contact JACK W HOWARD
Regulation Number886.4155
Classification Product Code
LXP  
Date Received11/10/1992
Decision Date 08/02/1993
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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