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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 K923628
Device Name CERVICAL LOOP ELECTRODE & ROLLERBALL ELECTRODE
Applicant
Bruce Mclucas
1140 Nineteenth St., NW
Washington,  DC  20036
Applicant Contact PETER O SADIR
Correspondent
Bruce Mclucas
1140 Nineteenth St., NW
Washington,  DC  20036
Correspondent Contact PETER O SADIR
Regulation Number884.4120
Classification Product Code
HGI  
Date Received07/21/1992
Decision Date 02/22/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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