FDA 510(k) Application Details - K970010

Device Classification Name Nebulizer (Direct Patient Interface)

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510(K) Number K970010
Device Name Nebulizer (Direct Patient Interface)
Applicant FLUID PROPULSION TECHNOLOGIES, INC.
3110 CORONADO DR.
SANTA CLARA, CA 95054 US
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Contact GEORGE JOHNSON
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Regulation Number 868.5630

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Classification Product Code CAF
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Date Received 01/02/1997
Decision Date 04/01/1997
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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