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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 K161568
Device Name Bone Solutions Mixing and Delivery System
Applicant
Bone Solutions, Inc.
5712 Colleyville Blvd.
Suite 210
Colleyville,  TX  76034
Applicant Contact DREW DIAZ
Correspondent
Bone Solutions, Inc.
5712 Colleyville Blvd.
Suite 210
Colleyville,  TX  76034
Correspondent Contact DREW DIAZ
Regulation Number880.5860
Classification Product Code
FMF  
Date Received06/07/2016
Decision Date 09/16/2016
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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