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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 K160578
Device Name Nustat XR
Applicant
Beeken Biomedical, LLC
292-G Page St.
Stoughton,  MA  02072
Applicant Contact DAN O'HARA
Correspondent
Regulatory Compliance Experts, Inc.
186 Old Farm Rd.
Abington,  MA  02351
Correspondent Contact SUSAN FINNERAN
Classification Product Code
QSY  
Date Received03/01/2016
Decision Date 06/29/2016
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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