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FDA 510(k) Application Details - K033565
Device Classification Name
Incubator, Neonatal Transport
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510(K) Number
K033565
Device Name
Incubator, Neonatal Transport
Applicant
LMT LAMMERS MEDICAL TECHNOLOGY GMBH
BESSEMERSTR. 7
LUEBECK 23562 DE
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Contact
THOMAS M BOHNEN
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Regulation Number
880.5410
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Classification Product Code
FPL
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More FDA Info for this Product Code
Date Received
11/12/2003
Decision Date
11/21/2003
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
Y
Expedited Review
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