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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 K895130
Device Name HEIMLICH MICRO TRACH
Applicant
BALLARD MEDICAL PRODUCTS
6864 SOUTH 300 WEST
MIDVALE,  UT  84047
Applicant Contact E.MARTIN CHAMBERLAIN
Correspondent
BALLARD MEDICAL PRODUCTS
6864 SOUTH 300 WEST
MIDVALE,  UT  84047
Correspondent Contact E.MARTIN CHAMBERLAIN
Regulation Number868.5800
Classification Product Code
BTO  
Date Received08/17/1989
Decision Date 11/07/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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