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FDA 510(k) Application Details - K072953
Device Classification Name
Devices, Breath Trapping, Alcohol
More FDA Info for this Device
510(K) Number
K072953
Device Name
Devices, Breath Trapping, Alcohol
Applicant
REDLINE PRODUCTS (PTY) LTD.
10 CROMPTON ROAD
STRAND INDUSTRIA, WESTERN CAPE 7140 ZA
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Contact
HUGH A BUTLER
Other 510(k) Applications for this Contact
Regulation Number
862.3050
More FDA Info for this Regulation Number
Classification Product Code
DJZ
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More FDA Info for this Product Code
Date Received
10/18/2007
Decision Date
01/07/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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