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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 K991725
Device Name SIDESTREAM NEBULIZER
Applicant
INSPIRED MEDICAL PRODUCTS LTD.
6329 W. WATERVIEW CT.
MCCORDSVILLE,  IN  46055 -9501
Applicant Contact PAUL E DRYDEN
Correspondent
INSPIRED MEDICAL PRODUCTS LTD.
6329 W. WATERVIEW CT.
MCCORDSVILLE,  IN  46055 -9501
Correspondent Contact PAUL E DRYDEN
Regulation Number868.5630
Classification Product Code
CAF  
Date Received05/20/1999
Decision Date 07/30/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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