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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheostomy (W/Wo Connector)
510(k) Number K924191
Device Name TRACHEOSTOMY CARE SET WITH GLOVES AND EXTRA TOWEL
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 Number868.5800
Classification Product Code
BTO  
Date Received08/20/1992
Decision Date 04/02/1993
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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