FDA 510(k) Application Details - K983467

Device Classification Name Spirometer, Therapeutic (Incentive)

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510(K) Number K983467
Device Name Spirometer, Therapeutic (Incentive)
Applicant DHD HEALTHCARE CORP.
125 RASBACH ST.
CANASTOTA, NY 13032 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 09/25/1998
Decision Date 04/02/1999
Decision SESE - SUBST EQUIV
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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