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FDA 510(k) Application Details - K031001
Device Classification Name
Electrode, Electrosurgical, Active, Urological
More FDA Info for this Device
510(K) Number
K031001
Device Name
Electrode, Electrosurgical, Active, Urological
Applicant
ACMI CORPORATION
136 TURNPIKE RD.
SOUTHBOROUGH, MA 01772 US
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Contact
GABRIEL J MURACA
Other 510(k) Applications for this Contact
Regulation Number
876.4300
More FDA Info for this Regulation Number
Classification Product Code
FAS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/31/2003
Decision Date
05/21/2003
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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