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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 K944854
Device Name STERISURE STERILIZATION WRAP
Applicant
FIBERWEB NORTH AMERICA, INC.
840 SOUTH EAST MAIN ST.
SIMPSONVILLE,  SC  29681
Applicant Contact CORNELIUS A CUNNINGHAM
Correspondent
FIBERWEB NORTH AMERICA, INC.
840 SOUTH EAST MAIN ST.
SIMPSONVILLE,  SC  29681
Correspondent Contact CORNELIUS A CUNNINGHAM
Regulation Number880.6850
Classification Product Code
FRG  
Date Received09/30/1994
Decision Date 12/19/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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