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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 K961973
Device Name DHD ACE WITH MASK KIT
Applicant
DHD DIEMOLDING HEALTHCARE DIV.
125 RASBACH ST.
CANASTOTA,  NY  13032
Applicant Contact JEAN WALLACE
Correspondent
DHD DIEMOLDING HEALTHCARE DIV.
125 RASBACH ST.
CANASTOTA,  NY  13032
Correspondent Contact JEAN WALLACE
Regulation Number868.5630
Classification Product Code
CAF  
Date Received05/20/1996
Decision Date 08/15/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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