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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Marker, Ocular
510(k) Number K863663
Device Name OPHTHALMIC SURGICAL OCULAR MARKERS
Applicant
Myocure, Inc.
1736 Flower St.
Glendale,  CA  91201
Applicant Contact ALEX C JENSEN
Correspondent
Myocure, Inc.
1736 Flower St.
Glendale,  CA  91201
Correspondent Contact ALEX C JENSEN
Regulation Number886.4570
Classification Product Code
HMR  
Date Received09/18/1986
Decision Date 10/20/1986
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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