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FDA 510(k) Application Details - K991575
Device Classification Name
Sterilizer, Steam
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510(K) Number
K991575
Device Name
Sterilizer, Steam
Applicant
PRIMUS STERILIZER CO., INC.
117 SOUTH 25TH ST.
OMAHA, NE 68131 US
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Contact
JEFF REED
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Regulation Number
880.6880
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Classification Product Code
FLE
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More FDA Info for this Product Code
Date Received
05/06/1999
Decision Date
12/03/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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