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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 K180937
Device Name Graftgun Universal Graft Delivery System
Applicant
SurGenTec, LLC
7601 N Federal Hwy #150a
Boca Raton,  FL  33487
Applicant Contact Boca Raton
Correspondent
Quality Solutions and Support
P.O. Box 8271
Holland,  MI  49422
Correspondent Contact Stephen W. Inglese
Regulation Number880.5860
Classification Product Code
FMF  
Date Received04/10/2018
Decision Date 05/10/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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