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FDA 510(k) Application Details - K973468
Device Classification Name
Nebulizer (Direct Patient Interface)
More FDA Info for this Device
510(K) Number
K973468
Device Name
Nebulizer (Direct Patient Interface)
Applicant
INVACARE CORP.
899 CLEVELAND ST.
P.O. BOX 4028
ELYRIA, OH 44036 US
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Contact
EDWARD A KROLL
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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
09/12/1997
Decision Date
12/08/1997
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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