FDA 510(k) Application Details - K980443

Device Classification Name Meter, Peak Flow, Spirometry

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510(K) Number K980443
Device Name Meter, Peak Flow, Spirometry
Applicant THE D&T, INC.
86 BEDFORD AVE.
HAMDEN, CT 06517 US
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Contact GEORGE DEBUSH
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Regulation Number 868.1860

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Classification Product Code BZH
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Date Received 02/05/1998
Decision Date 04/30/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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