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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 Rd.
St. Paul,  MN  55121
Applicant Contact TOM LOPAC
Correspondent
Micromedics, Inc.
1270 Eagan Industrial Rd.
St. Paul,  MN  55121
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
Predetermined Change
Control Plan Authorized		 No
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