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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 K173385
Device Name Graft Delivery, DePuy Synthes
Applicant
Micromedics, Inc. (d/b/a Nordson MEDICAL)
1270 Eagan Industrial Road, Suite 120
St. Paul,  MN  55121
Applicant Contact Kristi Brezinka
Correspondent
Micromedics, Inc. (d/b/a Nordson MEDICAL)
1270 Eagan Industrial Road, Suite 120
St. Paul,  MN  55121
Correspondent Contact Kristi Brezinka
Regulation Number880.5860
Classification Product Code
FMF  
Date Received10/30/2017
Decision Date 11/30/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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