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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer (Direct Patient Interface)
510(k) Number K921339
Device Name HAND-E-BREATH
Applicant
JERRY MCCARTY
8305 WINDWAY DR.
SAN ANTONIO,  TX  78239
Applicant Contact JERRY MCCARTY
Correspondent
JERRY MCCARTY
8305 WINDWAY DR.
SAN ANTONIO,  TX  78239
Correspondent Contact JERRY MCCARTY
Regulation Number868.5630
Classification Product Code
CAF  
Date Received03/18/1992
Decision Date 10/01/1992
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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