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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Ophthalmic
510(k) Number K880346
Device Name CANNULAS
Applicant
Myocure, Inc.
1736 Flower St.
Glendale,  CA  91201
Applicant Contact JENSEN, MD
Correspondent
Myocure, Inc.
1736 Flower St.
Glendale,  CA  91201
Correspondent Contact JENSEN, MD
Regulation Number886.4350
Classification Product Code
HMX  
Date Received01/26/1988
Decision Date 05/03/1988
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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