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FDA 510(k) Application Details - K955535
Device Classification Name
Chamber, Hyperbaric
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510(K) Number
K955535
Device Name
Chamber, Hyperbaric
Applicant
LOUISVILLE LABORATORIES, INC.
2400 CRITTENDEN DR.
LOUISVILLE, KY 40217-1865 US
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DAVID PHELPS
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Regulation Number
868.5470
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Classification Product Code
CBF
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Date Received
12/05/1995
Decision Date
07/01/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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