FDA 510(k) Application Details - K993051

Device Classification Name Incubator, Neonatal

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510(K) Number K993051
Device Name Incubator, Neonatal
Applicant HILL-ROM AIR-SHIELDS
330 JACKSONVILLE RD.
HATBORO, PA 19040 US
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Contact JAMES G CARPENTER
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Regulation Number 880.5400

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Classification Product Code FMZ
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Date Received 09/13/1999
Decision Date 02/03/2000
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 N
Expedited Review



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