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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 K072890
Device Name STASILON FR
Applicant
Entegrion, Inc.
79 Tw Alexander Dr. Suite 20
4401 Research Commons
Research Triangle Park,  NC  27709
Applicant Contact E.S. ESKRIDGE, JR.
Correspondent
Entegrion, Inc.
79 Tw Alexander Dr. Suite 20
4401 Research Commons
Research Triangle Park,  NC  27709
Correspondent Contact E.S. ESKRIDGE, JR.
Classification Product Code
QSY  
Date Received10/10/2007
Decision Date 12/10/2007
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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