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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 K000543
Device Name CONTEMPRO-MIST
Applicant
CONTEMPORARY PRODUCTS, INC.
530 RIVERSIDE INDUSTRIAL PWKY.
PORTLAND,  ME  04103 -1066
Applicant Contact BARRY A SCHWARTZ
Correspondent
CONTEMPORARY PRODUCTS, INC.
530 RIVERSIDE INDUSTRIAL PWKY.
PORTLAND,  ME  04103 -1066
Correspondent Contact BARRY A SCHWARTZ
Regulation Number868.5630
Classification Product Code
CAF  
Date Received02/18/2000
Decision Date 06/16/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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