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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dilator, cervical, hygroscopic-laminaria
510(k) Number K011512
Device Name MMODIFICATION TO LAMINARIA
Applicant
A & A MEDICAL, INC.
9370 INDUSTRIAL TRACE
ALPHARETTA,  GA  30004 -3383
Applicant Contact JIHAD (JAY) MANSOUR
Correspondent
A & A MEDICAL, INC.
9370 INDUSTRIAL TRACE
ALPHARETTA,  GA  30004 -3383
Correspondent Contact JIHAD (JAY) MANSOUR
Regulation Number884.4260
Classification Product Code
HDY  
Date Received05/16/2001
Decision Date 07/09/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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