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FDA 510(k) Application Details - K013348
Device Classification Name
Electrosurgical, Cutting & Coagulation & Accessories
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510(K) Number
K013348
Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Applicant
ERBE USA, INC.
2275 NORTHWEST PKWY., STE. 105
MARIETTA, GA 30067 US
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Contact
JOHN TARTAL
Other 510(k) Applications for this Contact
Regulation Number
878.4400
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Classification Product Code
GEI
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More FDA Info for this Product Code
Date Received
10/09/2001
Decision Date
10/26/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
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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