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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 K032809
Device Name HOSPITAL SPACER
Applicant
RESPIRONICS HEALTHSCAN, INC.
55 NORTHERN BLVD.,
SUITE 200
GREAT NECK,  NY  11021
Applicant Contact SUSAN D GOLDSTEIN-FALK
Correspondent
CITECH
5200 BUTLER PIKE
PLYMOUTH MEETING,  PA  19462 -1298
Correspondent Contact ROBERT MOSENKIS
Regulation Number868.5630
Classification Product Code
CAF  
Date Received09/09/2003
Decision Date 11/13/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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