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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Physical/Chemical Sterilization Process
510(k) Number K013228
Device Name 3M COMPLY 1248 GAS PLASMA CHEMICAL INDICATOR
Applicant
Minnesota Mining and Mfg. Co.
5353 Wayzata Blvd. Suite 505
Minneapolis,  MN  55416
Applicant Contact TIERNEY NORSTED
Correspondent
Minnesota Mining and Mfg. Co.
5353 Wayzata Blvd. Suite 505
Minneapolis,  MN  55416
Correspondent Contact TIERNEY NORSTED
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received09/27/2001
Decision Date 01/18/2002
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
Recalls CDRH Recalls
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