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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 K101528
Device Name 3M COMPLY LEAD FREE PROCESS INDICATORS FOR STEAM
Applicant
3M Company
3m Center, Bldg. 275-5w-06
St. Paul,  MN  55144 -1000
Applicant Contact SUZANNE LEUNG
Correspondent
3M Company
3m Center, Bldg. 275-5w-06
St. Paul,  MN  55144 -1000
Correspondent Contact SUZANNE LEUNG
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received06/02/2010
Decision Date 10/01/2010
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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