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FDA 510(k) Application Details - K112196
Device Classification Name
More FDA Info for this Device
510(K) Number
K112196
Device Name
OCTOTMPORT
Applicant
DALIM SURGNET CORPORATION
325 N PUENTE ST.
UNIT B
BREA, CA 92821 US
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Contact
APRIL LEE
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
OTJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/01/2011
Decision Date
09/14/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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