FDA 510(k) Application Details - K982408

Device Classification Name Nebulizer (Direct Patient Interface)

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510(K) Number K982408
Device Name Nebulizer (Direct Patient Interface)
Applicant PIPER MEDICAL PRODUCTS
3929 ARDERLY COURT
SACRAMENTO, CA 95826 US
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Contact S. DAVID PIPER
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Regulation Number 868.5630

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Classification Product Code CAF
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Date Received 07/10/1998
Decision Date 09/14/1998
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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