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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K994256
Device Name SUCTION IRRIGATION TRUMPET VALVE SET, MODEL Q65-823
Applicant
A & A Medical, Inc.
9370 Industrial Trace
Alpharetta,  GA  30004
Applicant Contact JIHAD MANSOUR
Correspondent
A & A Medical, Inc.
9370 Industrial Trace
Alpharetta,  GA  30004
Correspondent Contact JIHAD MANSOUR
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received12/17/1999
Decision Date 02/03/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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