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FDA 510(k) Application Details - K972466
Device Classification Name
Nebulizer (Direct Patient Interface)
More FDA Info for this Device
510(K) Number
K972466
Device Name
Nebulizer (Direct Patient Interface)
Applicant
HOLOPACK INTERNATIONAL, LP
1 TECHNOLOGY CIRCLE
COLUMBIA,, SC 29203 US
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Contact
JOHN J BARTHE
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Regulation Number
868.5630
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Classification Product Code
CAF
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More FDA Info for this Product Code
Date Received
07/01/1997
Decision Date
08/28/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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