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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 K915211
Device Name MICROCHAMBER
Applicant
RESPIRATORY DELIVERY SYSTEMS, INC.
70 MOUNT HOPE ST.
LOWELL,  MA  01854
Applicant Contact WALTER J MAKIEJ
Correspondent
RESPIRATORY DELIVERY SYSTEMS, INC.
70 MOUNT HOPE ST.
LOWELL,  MA  01854
Correspondent Contact WALTER J MAKIEJ
Regulation Number868.5630
Classification Product Code
CAF  
Date Received11/18/1991
Decision Date 05/20/1992
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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