FDA 510(k) Application Details - K052692

Device Classification Name Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed

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510(K) Number K052692
Device Name Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Applicant SURETEK MEDICAL
44 BELLWOOD FARMS
GREENVILLE, SC 29607 US
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Contact MIKE SAMMON
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Regulation Number 878.4400

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Classification Product Code NUJ
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Date Received 09/28/2005
Decision Date 05/10/2006
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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