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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 K952030
Device Name LOOP/SQUARE ELECTRODE
Applicant
E & M Engineering, Inc.
P.O. Box 11349
2116 Dabney Rd., Suite A-5
Richmond,  VA  23230
Applicant Contact WINNY CHOW
Correspondent
E & M Engineering, Inc.
P.O. Box 11349
2116 Dabney Rd., Suite A-5
Richmond,  VA  23230
Correspondent Contact WINNY CHOW
Regulation Number884.4120
Classification Product Code
HGI  
Date Received05/01/1995
Decision Date 07/31/1996
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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