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FDA 510(k) Application Details - K122971
Device Classification Name
Needle, Hypodermic, Single Lumen
More FDA Info for this Device
510(K) Number
K122971
Device Name
Needle, Hypodermic, Single Lumen
Applicant
P/L Biomedical
10882 STONIGTON AVE
FORT MYERS, FL 33913 US
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Contact
Lee Leichter
Other 510(k) Applications for this Contact
Regulation Number
880.5570
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Classification Product Code
FMI
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More FDA Info for this Product Code
Date Received
09/26/2012
Decision Date
10/25/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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