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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tape And Bandage, Adhesive
510(k) Number K924192
Device Name I.V. START KIT (AHC-50-54954
Applicant
AMERICAN HEALTHCARE CORP.
ONE AMERICAN HEALTHCARE PLAZA
3611 KENNEDY ROAD
SOUTH PLAINFIELD,  NJ  07080
Applicant Contact RALPH S JARRETT
Correspondent
AMERICAN HEALTHCARE CORP.
ONE AMERICAN HEALTHCARE PLAZA
3611 KENNEDY ROAD
SOUTH PLAINFIELD,  NJ  07080
Correspondent Contact RALPH S JARRETT
Regulation Number880.5240
Classification Product Code
KGX  
Subsequent Product Code
LRS  
Date Received08/20/1992
Decision Date 08/27/1993
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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