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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name percussor, powered-electric
510(k) Number K860510
Device Name NEONATE PERCUSSOR
Applicant
BALLARD MEDICAL PRODUCTS
6864 SOUTH 300 WEST
MIDVALE,  UT  84047
Applicant Contact E. M CHAMBERLAIN
Correspondent
BALLARD MEDICAL PRODUCTS
6864 SOUTH 300 WEST
MIDVALE,  UT  84047
Correspondent Contact E. M CHAMBERLAIN
Regulation Number868.5665
Classification Product Code
BYI  
Date Received02/11/1986
Decision Date 02/20/1986
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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