FDA 510(k) Application Details - K121855

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

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510(K) Number K121855
Device Name Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Applicant STRYKER SUSTAINABILITY SOLUTIONS
1810 WEST DRAKE DRIVE
TEMPE, AZ 85283 US
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Contact ERIC VARTY
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Regulation Number 878.4400

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Classification Product Code NUJ
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Date Received 06/25/2012
Decision Date 08/16/2012
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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