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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
Applicant
STRYKER SUSTAINABILITY SOLUTIONS
1810 west drake drive
tempe,  AZ  85283
Applicant Contact eric varty
Correspondent
STRYKER SUSTAINABILITY SOLUTIONS
1810 west drake drive
tempe,  AZ  85283
Correspodent Contact eric varty
Regulation Number878.4400
Classification Product Code
NUJ  
Date Received06/25/2012
Decision Date 08/16/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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