FDA 510(k) Application Details - K955104

Device Classification Name Nebulizer (Direct Patient Interface)

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510(K) Number K955104
Device Name Nebulizer (Direct Patient Interface)
Applicant AUTOMATIC LIQUID PACKAGING, INC.
2200 W. LAKE SHORE DR.
WOODSTOCK, IL 60098 US
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Contact JOHN BRDA
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Regulation Number 868.5630

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Classification Product Code CAF
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Date Received 11/08/1995
Decision Date 06/11/1996
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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