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FDA 510(k) Application Details - K972237
Device Classification Name
Nebulizer (Direct Patient Interface)
More FDA Info for this Device
510(K) Number
K972237
Device Name
Nebulizer (Direct Patient Interface)
Applicant
THAYER MEDICAL CORP.
4575 SOUTH PALO VERDE RD.,
SUITE 337
TUCSON, AZ 85714 US
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Contact
JOE LIX
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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
05/01/1997
Decision Date
07/31/1997
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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