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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K895812
Device Name SHARGHP INTRAVENOUS CATHETER
Applicant
SHARGH PHARMACEUTICAL CO., INC.
P.O. BOX 3194
CULVER CITY,  CA  90231
Applicant Contact ESHAHG HAMID
Correspondent
SHARGH PHARMACEUTICAL CO., INC.
P.O. BOX 3194
CULVER CITY,  CA  90231
Correspondent Contact ESHAHG HAMID
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received09/29/1989
Decision Date 09/07/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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