FDA 510(k) Application Details - K040439

Device Classification Name Nebulizer (Direct Patient Interface)

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510(K) Number K040439
Device Name Nebulizer (Direct Patient Interface)
Applicant NORTH AMERICAN TECHNICAL SERVICES (NATS) CORP.
30 NORTHPORT ROAD
SOUND BEACH, NY 11789-1734 US
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Contact RICHARD LANZILLOTTO
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Regulation Number 868.5630

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Classification Product Code CAF
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Date Received 02/19/2004
Decision Date 07/08/2004
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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