FDA 510(k) Application Details - K964994

Device Classification Name Nebulizer (Direct Patient Interface)

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510(K) Number K964994
Device Name Nebulizer (Direct Patient Interface)
Applicant CONTEMPORARY PRODUCTS, INC.
530 RIVERSIDE INDUSTRIAL PWKY.
PORTLAND, ME 04103-1066 US
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Contact BARRY A SCHWARTZ
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Regulation Number 868.5630

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Classification Product Code CAF
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Date Received 12/16/1996
Decision Date 02/21/1997
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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