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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 K041096
Device Name WAGNER STERISET STERILIZATION CONTAINER
Applicant
Wagner GmbH
22411 60th St.
Bristol,  WI  53104
Applicant Contact LARA N SIMMONS
Correspondent
Wagner GmbH
22411 60th St.
Bristol,  WI  53104
Correspondent Contact LARA N SIMMONS
Regulation Number880.6850
Classification Product Code
FRG  
Date Received04/27/2004
Decision Date 06/03/2005
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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