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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 K170675
Device Name Graftgun Universal Graft Delivery System
Applicant
SurGenTec, LLC
7601 N Federal Highway # 150b
Boca Raton,  FL  33487
Applicant Contact Travis Greenhalgh
Correspondent
SurGenTec, LLC
7601 N Federal Highway # 150b
Boca Raton,  FL  33487
Correspondent Contact Travis Greenhalgh
Regulation Number880.5860
Classification Product Code
FMF  
Date Received03/06/2017
Decision Date 07/19/2017
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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