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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 K120828
Model 39636, 39637, & 39638 (RESPECTIVELY)
Device Name BIATAIN SILICONE AG FOAM DRESSING - ADHESIVE: 3X3 INCHES, 4X4 INCHES, & 5X5 INCHES
Original Applicant
COLOPLAST A/S
1601 west river road north
minneapolis,  MN  55411
Original Contact rebeka stoltman
Classification Product Code
FRO  
Date Received03/19/2012
Decision Date 04/05/2012
Decision substantially equivalent (SE)
Review Advisory Committee General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product Yes
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