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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name syringe, irrigating (non dental)
510(k) Number K102563
Device Name SINGLE CANNULA EXTENDED APPLICATOR
Applicant
MICROMEDICS, INC.
1270 EAGAN INDUSTRIAL ROAD
ST PAUL,  MN  55121 -1385
Applicant Contact TOM LOPAC
Correspondent
MICROMEDICS, INC.
1270 EAGAN INDUSTRIAL ROAD
ST PAUL,  MN  55121 -1385
Correspondent Contact TOM LOPAC
Regulation Number880.6960
Classification Product Code
KYZ  
Date Received09/07/2010
Decision Date 03/15/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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