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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 K020589
Device Name 3M COMPLY 1228 GAS PLASMA INDICATOR TAPE
Applicant
3M Company
3m Center, Bldg. 275-5w-06
St. Paul,  MN  55133 -3275
Applicant Contact JOANN L HUEHN
Correspondent
3M Company
3m Center, Bldg. 275-5w-06
St. Paul,  MN  55133 -3275
Correspondent Contact JOANN L HUEHN
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received02/22/2002
Decision Date 04/22/2002
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
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