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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Knife, Ophthalmic
510(k) Number K874056
Device Name OPHTHALMIC DISPOSABLE BLADES
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
HNN  
Date Received10/05/1987
Decision Date 12/22/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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