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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 K061033
Device Name MILTEX RIGID STERILIZATION CONTAINER SYSTEM, (47 COMPONENTS)
Applicant
Miltex, Inc.
589 Davies Dr.
York,  PA  17402
Applicant Contact CHARLES WEAVER
Correspondent
Miltex, Inc.
589 Davies Dr.
York,  PA  17402
Correspondent Contact CHARLES WEAVER
Regulation Number880.6850
Classification Product Code
KCT  
Date Received04/14/2006
Decision Date 12/12/2006
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
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