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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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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