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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name spirometer, therapeutic (incentive)
510(k) Number K970596
Device Name DHD EMERALD PRODUCT
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 Number868.5690
Classification Product Code
BWF  
Date Received02/18/1997
Decision Date 05/16/1997
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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