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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, fistula
510(k) Number K013384
Device Name SHARGHP A.V. FISTULA NEEDLE SET
Applicant
SHARGH PHARMACEUTICAL CO., INC.
5840 WEST CENTINELA AVE.
BLDG. B
LOS ANGELES,  CA  90045
Applicant Contact ARMAND HAMEDANI
Correspondent
SHARGH PHARMACEUTICAL CO., INC.
5840 WEST CENTINELA AVE.
BLDG. B
LOS ANGELES,  CA  90045
Correspondent Contact ARMAND HAMEDANI
Regulation Number876.5540
Classification Product Code
FIE  
Date Received10/12/2001
Decision Date 01/07/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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