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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 K201338
Device Name Allograft MIS Delivery System
Applicant
Lifenet Health
1864 Concert Dr.
Virginia Beach,  VA  23453
Applicant Contact Brittany Beasley
Correspondent
Lifenet Health
1864 Concert Dr.
Virginia Beach,  VA  23453
Correspondent Contact Brittany Beasley
Regulation Number880.5860
Classification Product Code
FMF  
Date Received05/20/2020
Decision Date 07/13/2020
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
Predetermined Change
Control Plan Authorized		 No
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