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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 K112864
Device Name SOFTSEAL-C
Original Applicant
CHITOGEN, INC.
7255 ohms lane
minneapolis,  MN  55439
Original Contact james f drake
Classification Product Code
FRO  
Date Received09/30/2011
Decision Date 08/02/2012
Decision substantially equivalent (SESE)
510k Review Panel General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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