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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
Original Applicant
3M COMPANY-3M HEALTH CARE
3m center, bldg. 275-5w-06
st. paul,  MN  55144 1000
Original Contact maria ruiz
Classification Product Code
FRO  
Date Received03/14/2008
Decision Date 05/19/2008
Decision substantially equivalent (SE)
Review Advisory Committee Neurology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product Yes
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