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FDA 510(k) Application Details - K954803
Device Classification Name
Gas, Calibration (Specified Concentration)
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510(K) Number
K954803
Device Name
Gas, Calibration (Specified Concentration)
Applicant
MITTLER SUPPLY, INC.
3607 SOUTH MAIN ST.
SOUTH BEND, IN 46614 US
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Contact
DAVID FINNEY
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Regulation Number
868.6400
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Classification Product Code
BXK
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More FDA Info for this Product Code
Date Received
10/19/1995
Decision Date
01/25/1996
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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