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FDA 510(k) Application Details - K011190
Device Classification Name
More FDA Info for this Device
510(K) Number
K011190
Device Name
SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX LP SYSTEM)
Applicant
SURX, INC.
6900 KOLL CENTER PKWY., #417
PLEASANTON, CA 94566 US
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Contact
ALAN CURTIS
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
MUK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/19/2001
Decision Date
01/08/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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