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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K183009
Device Name HEMOSTATIX MODEL P8400 DISPOSABLE HANDLE, HEMOSTATIX MODEL P8400 DISPOSABLE BLADES
Applicant
Hemostatix Medical Technologies, LLC
8400 Wolf Lake Dr., Suite 109
Bartlett,  TN  38133
Applicant Contact Jeff Cobb
Correspondent
Hemostatix Medical Technologies, LLC
8400 Wolf Lake Dr., Suite 109
Bartlett,  TN  38133
Correspondent Contact Jeff Cobb
Regulation Number878.4400
Classification Product Code
GEI  
Date Received10/31/2018
Decision Date 11/26/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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