FDA 510(k) Application Details - K931603

Device Classification Name Nebulizer (Direct Patient Interface)

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510(K) Number K931603
Device Name Nebulizer (Direct Patient Interface)
Applicant STERIMATICS CO.
PATRIOTS PARK
BEDFORD, MA US
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Contact THOMAS BORROWS
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Regulation Number 868.5630

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Classification Product Code CAF
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Date Received 04/01/1993
Decision Date 05/13/1993
Decision SE - Substantially Equivalent
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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