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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 K942403
Device Name INFUSION CANNULA
Applicant
Microsurgical Technology, Inc.
P.O. Box 675
Kirkland,  WA  98083
Applicant Contact ISIDRO NILSSON
Correspondent
Microsurgical Technology, Inc.
P.O. Box 675
Kirkland,  WA  98083
Correspondent Contact ISIDRO NILSSON
Regulation Number886.4350
Classification Product Code
HMX  
Date Received05/19/1994
Decision Date 08/17/1994
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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