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FDA 510(k) Application Details - K150190
Device Classification Name
Warmer, Irrigation Solution
More FDA Info for this Device
510(K) Number
K150190
Device Name
Warmer, Irrigation Solution
Applicant
Ecolab Inc.
370 Wabasha Street North
St. Paul, MN 55102-1390 US
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Contact
Michelle Nivala
Other 510(k) Applications for this Contact
Regulation Number
000.0000
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Classification Product Code
LHC
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More FDA Info for this Product Code
Date Received
01/27/2015
Decision Date
02/26/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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