FDA 510(k) Application Details - K962182

Device Classification Name Hood, Oxygen, Infant

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510(K) Number K962182
Device Name Hood, Oxygen, Infant
Applicant PROMEDIC, INC.
6329 WEST WATERVIEW CT.
MCCORDSVILLE, IN 46055-9501 US
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Contact PAUL E DRYDEN
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Regulation Number 868.5700

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Classification Product Code FOG
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Date Received 06/06/1996
Decision Date 07/15/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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