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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 K101257
Device Name ADVANCED TRAUMA DRESSING (ATD)
Applicant
Nanosys, Inc.
2625 Hanover St.
Palo Alto,  CA  94304
Applicant Contact HUGH DANIELS
Correspondent
Nanosys, Inc.
2625 Hanover St.
Palo Alto,  CA  94304
Correspondent Contact HUGH DANIELS
Classification Product Code
QSY  
Date Received05/04/2010
Decision Date 12/01/2011
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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