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FDA 510(k) Application Details - K081678
Device Classification Name
Electrosurgical, Cutting & Coagulation & Accessories
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510(K) Number
K081678
Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Applicant
KLS MARTIN GMBH + CO. KG
AM GANSACKER 1B
UMKIRCH 79224 DE
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Contact
BERNHARD HUG
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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
06/17/2008
Decision Date
07/29/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
Y
Expedited Review
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