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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 K010825
Device Name MEDLINE STERISET STERILIZATION CONTAINER
Applicant
MEDLINE
ONE MEDLINE PLACE
MUNDLELEIN,  IL  60060
Applicant Contact STACEY L BOLEN
Correspondent
MEDLINE
ONE MEDLINE PLACE
MUNDLELEIN,  IL  60060
Correspondent Contact STACEY L BOLEN
Regulation Number880.6850
Classification Product Code
FRG  
Date Received03/19/2001
Decision Date 05/08/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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