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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 K142661
Device Name Bi-Portal Bone Graft Delivery Device
Applicant
Spinal Surgical Strategies, LLC
999 Dr.R Way
Incline Village,  NV  89541
Applicant Contact Jeffrey Kleiner
Correspondent
C/O Spinal Surgical Strategies
999 Dr.R Way
Incline Village,  NV  89541
Correspondent Contact Tim Reeves
Regulation Number880.5860
Classification Product Code
FMF  
Date Received09/18/2014
Decision Date 12/11/2014
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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