FDA 510(k) Application Details - K960675

Device Classification Name Nebulizer (Direct Patient Interface)

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510(K) Number K960675
Device Name Nebulizer (Direct Patient Interface)
Applicant PARI HOLDING CO.
7493 WHITEPINE RD.
RICHMOND, VA 23237 US
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Contact MIGUEL A ARRIZON
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Regulation Number 868.5630

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Classification Product Code CAF
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Date Received 02/20/1996
Decision Date 05/17/1996
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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