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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 K892117
Device Name GENTLEHALER(R)
Applicant
SCHERING RESEARCH
2000 GALLOPING HILL RD.
KENILWORTH,  NJ  07033
Applicant Contact ALEXANDER GIAQUINTO
Correspondent
SCHERING RESEARCH
2000 GALLOPING HILL RD.
KENILWORTH,  NJ  07033
Correspondent Contact ALEXANDER GIAQUINTO
Regulation Number868.5640
Classification Product Code
CCQ  
Date Received03/31/1989
Decision Date 06/23/1989
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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