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FDA 510(k) Application Details - K033381
Device Classification Name
Sterilant, Medical Devices
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510(K) Number
K033381
Device Name
Sterilant, Medical Devices
Applicant
DISCUS DENTAL INC.
8550 HIGUERA ST.
CULVER CITY, CA 90232 US
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Contact
STEVEN L ZIEMBA
Other 510(k) Applications for this Contact
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
10/22/2003
Decision Date
01/27/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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