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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K100754
Device Name GRAFT DELIVERY SYSTEM MODEL SA-6115
Applicant
Micromedics, Inc.
1270 Eagan Industrial Rd.
St. Paul,  MN  55121
Applicant Contact THOMAS A LOPAC
Correspondent
Micromedics, Inc.
1270 Eagan Industrial Rd.
St. Paul,  MN  55121
Correspondent Contact THOMAS A LOPAC
Regulation Number880.5860
Classification Product Code
FMF  
Date Received03/17/2010
Decision Date 06/09/2010
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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