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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 K080620
Device Name MODIFICATION TO 3M TEGADERM CHG DRESSING
Applicant
3M Company-3M Health Care
3m Center, Bldg. 275-5w-06
St. Paul,  MN  55144 -1000
Applicant Contact MARIA RUIZ
Correspondent
3M Company-3M Health Care
3m Center, Bldg. 275-5w-06
St. Paul,  MN  55144 -1000
Correspondent Contact MARIA RUIZ
Classification Product Code
FRO  
Date Received03/04/2008
Decision Date 05/19/2008
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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