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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K123679
Device Name 3M TEGADERM CHG CHLORHEXIDINE GLUCONATE I.V. PORT DRESSING
Applicant
3M Company
3m Center
2510 Conway Ave., Bldg. 275-5w-06
St. Paul,  MN  55144
Applicant Contact JOANN HUEHN
Correspondent
3M Company
3m Center
2510 Conway Ave., Bldg. 275-5w-06
St. Paul,  MN  55144
Correspondent Contact JOANN HUEHN
Classification Product Code
FRO  
Date Received11/30/2012
Decision Date 02/28/2013
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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