FDA 510(k) Application Details - K053282

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K053282
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant PAJUNK GMBH
KARL-HALL-STRASSE 1
GEISINGEN D-78187 DE
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Contact CHRISTIAN QUASS
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 11/25/2005
Decision Date 12/13/2005
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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