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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Irrigation, Ocular Surgery
510(k) Number K871454
Device Name MORGAN THERAPEUTIC LENS
Applicant
Mortan, Inc.
P.O. Box 3478
Missoula,  MT  59806
Applicant Contact SAM WAGNER
Correspondent
Mortan, Inc.
P.O. Box 3478
Missoula,  MT  59806
Correspondent Contact SAM WAGNER
Regulation Number886.4360
Classification Product Code
KYG  
Date Received04/13/1987
Decision Date 06/19/1987
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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