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FDA 510(k) Application Details - K021742
Device Classification Name
Nebulizer (Direct Patient Interface)
More FDA Info for this Device
510(K) Number
K021742
Device Name
Nebulizer (Direct Patient Interface)
Applicant
GALEMED CORP.
29201 VIA NORTE
TEMECULA, CA 92591 US
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Contact
TOM SHANKS
Other 510(k) Applications for this Contact
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
05/28/2002
Decision Date
10/25/2002
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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