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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 K000355
Device Name 3M COMPLY 1249 LIQUID PERACETIC ACID CHEMICAL INDICATOR
Applicant
Minnesota Mining and Mfg. Co.
3m Center
St. Paul,  MN  55144
Applicant Contact GRETCHEN KEENAN
Correspondent
Minnesota Mining and Mfg. Co.
3m Center
St. Paul,  MN  55144
Correspondent Contact GRETCHEN KEENAN
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received02/04/2000
Decision Date 08/23/2000
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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