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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Laparoscopic
510(k) Number K000027
Device Name INSUFFLATION NEEDLE, MODEL R65-933
Applicant
A & A Medical, Inc.
9370 Industrial Trace
Alpharetta,  GA  30004 -3383
Applicant Contact JIHAD MANSOUR
Correspondent
A & A Medical, Inc.
9370 Industrial Trace
Alpharetta,  GA  30004 -3383
Correspondent Contact JIHAD MANSOUR
Regulation Number884.1730
Classification Product Code
HIF  
Date Received01/05/2000
Decision Date 04/03/2000
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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