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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical
510(k) Number K140250
Device Name 3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE
Applicant
3M Healthcare
3m Center
2510 Conway Ave., Bldg. 275-5w-06
St. Paul,  MN  55144
Applicant Contact KRISTIN TOTUSHEK
Correspondent
3M Healthcare
3m Center
2510 Conway Ave., Bldg. 275-5w-06
St. Paul,  MN  55144
Correspondent Contact KRISTIN TOTUSHEK
Regulation Number878.4370
Classification Product Code
KKX  
Date Received01/31/2014
Decision Date 07/25/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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