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FDA 510(k) Application Details - K061110
Device Classification Name
Calculator, Drug Dose
More FDA Info for this Device
510(K) Number
K061110
Device Name
Calculator, Drug Dose
Applicant
COLLABORATIVEMED, LLC
14-D PELHAM RIDGE DRIVE
GREENVILLE, SC 29615 US
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Contact
ROBERT BOOTH
Other 510(k) Applications for this Contact
Regulation Number
868.1890
More FDA Info for this Regulation Number
Classification Product Code
NDC
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More FDA Info for this Product Code
Date Received
04/20/2006
Decision Date
06/07/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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