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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 K873793
Device Name INSPIREASE(R), DRUG DELIVERY SYSTEM
Applicant
KEY PHARMACEUTICALS, INC.
2000 GALLOPING HILL RD.
KENILWORTH,  NJ  07033
Applicant Contact ALEXANDER GIAQUINTO
Correspondent
KEY PHARMACEUTICALS, INC.
2000 GALLOPING HILL RD.
KENILWORTH,  NJ  07033
Correspondent Contact ALEXANDER GIAQUINTO
Regulation Number868.5640
Classification Product Code
CCQ  
Date Received09/17/1987
Decision Date 10/13/1987
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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