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FDA 510(k) Application Details - K072404
Device Classification Name
Lavage, Jet
More FDA Info for this Device
510(K) Number
K072404
Device Name
Lavage, Jet
Applicant
ERBE USA, INC.
2225 NORTHWEST PKWY.
MARIETTA, GA 30067 US
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Contact
JOHN TARTAL
Other 510(k) Applications for this Contact
Regulation Number
880.5475
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Classification Product Code
FQH
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More FDA Info for this Product Code
Date Received
08/27/2007
Decision Date
10/31/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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