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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 K974138
Device Name ROCKET ELECTRODE
Applicant
A & A Medical, Inc.
4100 Nine Mcfarland Dr., #B
Alpharetta,  GA  30201
Applicant Contact JIHAD MANSOUR
Correspondent
A & A Medical, Inc.
4100 Nine Mcfarland Dr., #B
Alpharetta,  GA  30201
Correspondent Contact JIHAD MANSOUR
Regulation Number884.4120
Classification Product Code
HGI  
Date Received11/03/1997
Decision Date 01/30/1998
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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