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FDA 510(k) Application Details - K955805
Device Classification Name
Nebulizer (Direct Patient Interface)
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510(K) Number
K955805
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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Date Received
12/22/1995
Decision Date
03/21/1996
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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