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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 K052567
Device Name ONE TRAY SEALED STERILIZATION CONTAINER
Applicant
Sterile Containment Technology, LLC
1301 Quarry Ct., Suite 204
Point Richmond,  CA  94801
Applicant Contact GAGE GARMAN
Correspondent
Sterile Containment Technology, LLC
1301 Quarry Ct., Suite 204
Point Richmond,  CA  94801
Correspondent Contact GAGE GARMAN
Regulation Number880.6850
Classification Product Code
KCT  
Date Received09/19/2005
Decision Date 03/13/2006
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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