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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 K973532
Device Name STEALTH, METERED DOSE INHALER (MDI) SPACER WITHOUT INTEGRAL ACTUATOR
Applicant
DHD DIEMOLDING HEALTHCARE DIV.
MADISON ST.
WAMPSVILLE,  NY  13163
Applicant Contact JEAN WALLACE
Correspondent
DHD DIEMOLDING HEALTHCARE DIV.
MADISON ST.
WAMPSVILLE,  NY  13163
Correspondent Contact JEAN WALLACE
Regulation Number868.5630
Classification Product Code
CAF  
Date Received09/18/1997
Decision Date 03/19/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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