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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrosurgical, cutting & coagulation accessories, laparoscopic & endoscopic, reprocessed
510(k) Number K121855
Device Name RESPROCESSED SERFAS ENERGY PROBE
Original Applicant
STRYKER SUSTAINABILITY SOLUTIONS
1810 west drake drive
tempe,  AZ  85283
Original Contact eric varty
Regulation Number878.4400
Classification Product Code
NUJ  
Date Received06/25/2012
Decision Date 08/16/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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