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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 K042655
Device Name INSPIRATION ELITE NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS456
Applicant
RESPIRONICS NEW JERSEY, INC.
41 CANFIELD RD.
CEDAR GROVE,  NJ  07009
Applicant Contact Lauren Ziegler
Correspondent
ENTELA, INC.
3033 MADISON AVENUE, SE
GRAND RAPIDS,  MI  49548
Correspondent Contact NED DEVINE
Regulation Number868.5630
Classification Product Code
CAF  
Subsequent Product Code
BTI  
Date Received09/28/2004
Decision Date 10/13/2004
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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