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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Tissue Approximation Device
510(k) Number K003949
Device Name TACKER, MODEL R65-933
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
OCW  
Date Received12/21/2000
Decision Date 07/25/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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