FDA 510(k) Application Details - K914283

Device Classification Name Nebulizer (Direct Patient Interface)

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510(K) Number K914283
Device Name Nebulizer (Direct Patient Interface)
Applicant THAYER MEDICAL CORP.
4500 EAST SPEEDWAY BLVD.
SUITE 20
TUCSON, AZ US
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Contact DAVID SLADEK
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Regulation Number 868.5630

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Classification Product Code CAF
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Date Received 09/24/1991
Decision Date 02/26/1992
Decision SE - Substantially Equivalent
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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