FDA 510(k) Application Details - K944900

Device Classification Name Spirometer, Therapeutic (Incentive)

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510(K) Number K944900
Device Name Spirometer, Therapeutic (Incentive)
Applicant DHD DIEMOLDING HEALTHCARE DIV.
125 RASBACH ST.
CANASTOTA, NY US
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Contact JEAN WALLACE
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Regulation Number 868.5690

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Classification Product Code BWF
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Date Received 10/04/1994
Decision Date 01/06/1995
Decision SE - Substantially Equivalent
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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