FDA 510(k) Application Details - K040855

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K040855
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant INSTRUMED INTERNATIONAL, INC.
KAISERSTR. 9
TUNINGEN, B.W. 78609 DE
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Contact HAIKO BELL
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 04/02/2004
Decision Date 04/16/2004
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 Y
Expedited Review



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