FDA 510(k) Application Details - K062052

Device Classification Name Incubator, Neonatal Transport

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510(K) Number K062052
Device Name Incubator, Neonatal Transport
Applicant LMT LAMMERS MEDICAL TECHNOLOGY GMBH
OSTERWEIDE 8
LUEBECK 23568 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 07/20/2006
Decision Date 07/31/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review

FDA Source Information for K062052


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