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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 K953206
Device Name DHD METERED DOSE INHALER (MDI) SPACER (MODIFICATION)
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 Received05/30/1995
Decision Date 08/28/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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