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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name nebulizer, medicinal, non-ventilatory (atomizer)
510(k) Number K832037
Device Name INSPIREASE
Applicant
KEY PHARMACEUTICALS, INC.
C/O SCHERING CORP.
2000 GALLOPING HILL RD
KENILWORTH,  NJ  07033 -
Applicant Contact ALENDER GIAQUINTO
Correspondent
KEY PHARMACEUTICALS, INC.
C/O SCHERING CORP.
2000 GALLOPING HILL RD
KENILWORTH,  NJ  07033 -
Correspondent Contact ALENDER GIAQUINTO
Regulation Number868.5640
Classification Product Code
CCQ  
Date Received06/24/1983
Decision Date 08/16/1983
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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