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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Sterilization
510(k) Number K153025
Device Name Turbett Surgical Container
Applicant
Turbett Surgical, LLC
125 Tech Park Dr. Suite 2108
Rochester,  NY  14623
Applicant Contact ROB TURBETT
Correspondent
Fdc Services
8708 Capehart Cove
Austin,  TX  78733
Correspondent Contact DAVID FURR
Regulation Number880.6850
Classification Product Code
FRG  
Date Received10/16/2015
Decision Date 01/14/2016
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
Recalls CDRH Recalls
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