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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 K070877
Device Name ENDOCERVICAL ELECTRODE # 2
Applicant
Modern Medical Equipment Mfg., Ltd.
1705 Dabney Rd.
Richmond,  VA  23230
Applicant Contact BOB STILLMAN
Correspondent
Modern Medical Equipment Mfg., Ltd.
1705 Dabney Rd.
Richmond,  VA  23230
Correspondent Contact BOB STILLMAN
Regulation Number884.4120
Classification Product Code
HGI  
Date Received03/29/2007
Decision Date 07/27/2007
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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