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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 K072563
Device Name MILTEX RIGID CONTAINER SYSTEMS
Applicant
Miltex, Inc.
589 Davies Dr.
York,  PA  17402
Applicant Contact PATRICIA KIHN
Correspondent
Miltex, Inc.
589 Davies Dr.
York,  PA  17402
Correspondent Contact PATRICIA KIHN
Regulation Number880.6850
Classification Product Code
KCT  
Date Received09/11/2007
Decision Date 02/12/2008
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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