FDA 510(k) Application Details - K102831

Device Classification Name Chamber, Hyperbaric

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510(K) Number K102831
Device Name Chamber, Hyperbaric
Applicant REIMERS SYSTEMS, INC.
8210-D CINDERBED RD.
LORTON, VA 22079 US
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Contact NAYIL ALAM
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Regulation Number 868.5470

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Classification Product Code CBF
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Date Received 09/29/2010
Decision Date 08/19/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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