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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name nebulizer, medicinal, non-ventilatory (atomizer)
510(k) Number K872315
Device Name MISTMASTER
Applicant
SONORA RESPIRATORY PRODUCTS, INC.
1180-Z STAR ROUTE
SONORA,  CA  95370
Applicant Contact EDWARD J SVOBODA
Correspondent
SONORA RESPIRATORY PRODUCTS, INC.
1180-Z STAR ROUTE
SONORA,  CA  95370
Correspondent Contact EDWARD J SVOBODA
Regulation Number868.5640
Classification Product Code
CCQ  
Date Received06/17/1987
Decision Date 09/11/1987
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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