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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 K912566
Device Name MINITROP AEROSOL UNIT
Applicant
HEYER AMERICA, INC.
2550 M ST. N.W.
WASHINGTON,  DC  20037
Applicant Contact STUART M PAPE
Correspondent
HEYER AMERICA, INC.
2550 M ST. N.W.
WASHINGTON,  DC  20037
Correspondent Contact STUART M PAPE
Regulation Number868.5630
Classification Product Code
CAF  
Date Received06/11/1991
Decision Date 08/20/1991
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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