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FDA 510(k) Application Details - K091210
Device Classification Name
Sterilant, Medical Devices
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510(K) Number
K091210
Device Name
Sterilant, Medical Devices
Applicant
BEST SANITIZERS, INC.
1107-C SOUTH AIRPORT CIRCLE
EULESS, TX 76040 US
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Contact
NORMAN MINER
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Regulation Number
880.6885
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Classification Product Code
MED
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More FDA Info for this Product Code
Date Received
04/24/2009
Decision Date
02/05/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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