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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 K903413
Device Name MICROSPACER TM
Applicant
RESPIRATORY DELIVERY SYSTEMS, INC.
70 MOUNT HOPE ST.
LOWELL,  MA  01854
Applicant Contact MAKIEJ JR.
Correspondent
RESPIRATORY DELIVERY SYSTEMS, INC.
70 MOUNT HOPE ST.
LOWELL,  MA  01854
Correspondent Contact MAKIEJ JR.
Regulation Number868.5630
Classification Product Code
CAF  
Date Received07/30/1990
Decision Date 10/09/1990
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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