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FDA 510(k) Application Details - K051247
Device Classification Name
Kit, Needle, Biopsy
More FDA Info for this Device
510(K) Number
K051247
Device Name
Kit, Needle, Biopsy
Applicant
MEDI-GLOBE CORP.
110 WEST ORION, SUITE 136
TEMPE, AZ 85283 US
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Contact
SCOTT KARLER
Other 510(k) Applications for this Contact
Regulation Number
876.1075
More FDA Info for this Regulation Number
Classification Product Code
FCG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/16/2005
Decision Date
06/16/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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