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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 K091194
Device Name ALGISEAL PAD
Applicant
Evolution Medical Technologies, LLC
3439 NE Sandy Blvd.
Suite 142
Portland,  OR  97232
Applicant Contact JOHN MANNING
Correspondent
Evolution Medical Technologies, LLC
3439 NE Sandy Blvd.
Suite 142
Portland,  OR  97232
Correspondent Contact JOHN MANNING
Classification Product Code
QSY  
Date Received04/23/2009
Decision Date 05/18/2009
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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