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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
510(k) Number K972856
Device Name ULTRA-FINE DIATHERMY LOOP AND COAGULATION BALLS
Applicant
Rocket Medical Plc
Tyne & Wear
Washington,  GB NE37 1NE
Applicant Contact L. TODD
Correspondent
Rocket Medical Plc
Tyne & Wear
Washington,  GB NE37 1NE
Correspondent Contact L. TODD
Regulation Number884.4160
Classification Product Code
KNF  
Date Received08/01/1997
Decision Date 02/11/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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