FDA 510(k) Application Details - K051260

Device Classification Name Nebulizer (Direct Patient Interface)

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510(K) Number K051260
Device Name Nebulizer (Direct Patient Interface)
Applicant ALLIED HEALTHCARE PRODUCTS, INC.
1720 SUBLETTE AVE.
ST. LOUIS, MO 63110 US
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Contact WAYNE KARCHER
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Regulation Number 868.5630

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Classification Product Code CAF
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Date Received 05/15/2005
Decision Date 09/15/2005
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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