FDA 510(k) Application Details - K961455

Device Classification Name Nebulizer, Medicinal, Non-Ventilatory (Atomizer)

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510(K) Number K961455
Device Name Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
Applicant DIEMOLDING CORP.
125 RASBACH ST.
CANASTOTA, NY 13032 US
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Contact JEAN WALLACE
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Regulation Number 868.5640

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Classification Product Code CCQ
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Date Received 04/16/1996
Decision Date 07/25/1996
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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