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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 K002021
Device Name HEMOSTATIX THERMAL SCALPEL SYSTEM - #12 BLADE
Applicant
Gyrus Ent LLC
2925 Appling Rd.
Bartlett,  TN  38133
Applicant Contact ALICIA FARAGE
Correspondent
Gyrus Ent LLC
2925 Appling Rd.
Bartlett,  TN  38133
Correspondent Contact ALICIA FARAGE
Regulation Number878.4400
Classification Product Code
GEI  
Date Received07/03/2000
Decision Date 08/24/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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