FDA 510(k) Application Details - K992986

Device Classification Name Nebulizer (Direct Patient Interface)

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510(K) Number K992986
Device Name Nebulizer (Direct Patient Interface)
Applicant SALTER LABS
100 WEST SYCAMORE RD.
ARVIN, CA 93203 US
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Contact DUANE KAZAL
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Regulation Number 868.5630

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Classification Product Code CAF
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Date Received 09/03/1999
Decision Date 09/24/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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