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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 K200431
Device Name 3D GraftRasp System
Applicant
SurGenTec
911 Clint Moore Rd
Boca Raton,  FL  33847
Applicant Contact Andrew Shoup
Correspondent
SurGenTec
911 Clint Moore Rd
Boca Raton,  FL  33847
Correspondent Contact Andrew Shoup
Regulation Number880.5860
Classification Product Code
FMF  
Date Received02/21/2020
Decision Date 05/18/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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