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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 K091107
Device Name MODEL P8400 HEMOSTATIX THERMAL SCALPEL SYSTEM
Applicant
HEMOSTATIX MEDICAL TECHNOLOGIES, LLC
8400 WOLF LAKE DR., STE. 109
BARTLETT,  TN  38133
Applicant Contact JEFF COBB
Correspondent
UNDERWRITERS LABORATORIES, INC.
1285 WALT WHITMAN RD.
MELVILLE,  NY  11747
Correspondent Contact CASEY CONRY
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/16/2009
Decision Date 05/01/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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