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FDA 510(k) Application Details - K973133
Device Classification Name
Pump, Infusion
More FDA Info for this Device
510(K) Number
K973133
Device Name
Pump, Infusion
Applicant
BYRON MEDICAL
3280 E. HEMISPHERE LOOP
SUITE 100
TUCSON, AZ 85706 US
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Contact
STEVE BOLLINGER
Other 510(k) Applications for this Contact
Regulation Number
880.5725
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Classification Product Code
FRN
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More FDA Info for this Product Code
Date Received
08/21/1997
Decision Date
09/12/1997
Decision
ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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