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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hemostatic Wound Dressing Without Thrombin Or Other Biologics
510(k) Number K112864
Device Name SOFTSEAL-C
Applicant
Chitogen, Inc.
7255 Ohms Ln.
Minneapolis,  MN  55439
Applicant Contact JAMES F DRAKE
Correspondent
Chitogen, Inc.
7255 Ohms Ln.
Minneapolis,  MN  55439
Correspondent Contact JAMES F DRAKE
Classification Product Code
QSY  
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
Predetermined Change
Control Plan Authorized		 No
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