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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Temporary, Internal Use Hemostatic
510(k) Number K183190
Device Name NuStat
Applicant
Beeken Biomedical, LLC
378 Page St., Suite 201
Stoughton,  MA  02072
Applicant Contact Richard A. Kendall
Correspondent
Alira Health
1 Grant St., Suite 400
Framingham,  MA  01702
Correspondent Contact Mary McNamara
Regulation Number878.4454
Classification Product Code
POD  
Date Received11/19/2018
Decision Date 09/25/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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