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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(k) Number K110898
Device Name S.C.O.R.E.S. UNIT
Applicant
Ammed Surgical Equipment, LLC
8708 Capehart Cove
Austin,  TX  78733
Applicant Contact DAVID C FURR
Correspondent
Ammed Surgical Equipment, LLC
8708 Capehart Cove
Austin,  TX  78733
Correspondent Contact DAVID C FURR
Regulation Number880.6850
Classification Product Code
KCT  
Date Received03/30/2011
Decision Date 07/26/2012
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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