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FDA 510(k) Application Details - K030919
Device Classification Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories), Reprocessed
More FDA Info for this Device
510(K) Number
K030919
Device Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories), Reprocessed
Applicant
MEDISISS
723 CURTIS COURT
PO BOX 2060
SISTERS, OR 97759 US
Other 510(k) Applications for this Company
Contact
MRRY ANN BARKER
Other 510(k) Applications for this Contact
Regulation Number
876.4300
More FDA Info for this Regulation Number
Classification Product Code
NLR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/24/2003
Decision Date
07/03/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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