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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrode, electrosurgical, active, urological
510(k) Number K955531
Device Name ARTHROCARE BIPOLAR LOOP ELECTRODE SYSTEM
Applicant
ARTHROCARE CORP.
595 NORTH PASTORIA AVE.
SUNNYVALE,  CA  94085 -2936
Applicant Contact CHERYL L SHEA
Correspondent
ARTHROCARE CORP.
595 NORTH PASTORIA AVE.
SUNNYVALE,  CA  94085 -2936
Correspondent Contact CHERYL L SHEA
Regulation Number876.4300
Classification Product Code
FAS  
Subsequent Product Code
KNS  
Date Received12/04/1995
Decision Date 02/21/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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