FDA 510(k) Application Details - K042077

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K042077
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant GUENTER BISSINGER MEDIZINTECHNIK GMBH
47 GRIESWEG
MUEHLHEIM, BADEN-WUERTTEMBERG 78570 DE
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Contact FRANZ MENEAN
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 08/02/2004
Decision Date 10/27/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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