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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocautery, Gynecologic (And Accessories)
510(k) Number K993777
Device Name DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES
Applicant
R-Group Intl.
2321 NW 66th Ct., Suite W-4
Gainesville,  FL  32653
Applicant Contact KERRY A KAHN
Correspondent
R-Group Intl.
2321 NW 66th Ct., Suite W-4
Gainesville,  FL  32653
Correspondent Contact KERRY A KAHN
Regulation Number884.4120
Classification Product Code
HGI  
Date Received11/08/1999
Decision Date 05/25/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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