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FDA 510(k) Application Details - K033880
Device Classification Name
Electrosurgical, Cutting & Coagulation & Accessories
More FDA Info for this Device
510(K) Number
K033880
Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Applicant
MECTRA LABS, INC.
HIGHWAY 231 SOUTH,
2 QUALITY WAY
BLOOMFIELD, IN 47424 US
Other 510(k) Applications for this Company
Contact
CHARLES E ALLGOOD JR.
Other 510(k) Applications for this Contact
Regulation Number
878.4400
More FDA Info for this Regulation Number
Classification Product Code
GEI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/15/2003
Decision Date
03/10/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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