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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, anesthesia, paracervical
510(k) Number K973671
Device Name ENDOCERVICAL BLOCK NEEDLE
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 Number884.5100
Classification Product Code
HEE  
Subsequent Product Code
FMI  
Date Received09/26/1997
Decision Date 11/26/1997
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
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