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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
510(k) Number K000036
Device Name ENTEC REFLEX WAND 55, MODEL E4055-00
Applicant
Arthrocare Corp.
595 N. Pastoria Ave.
Sunnyvale,  CA  94085
Applicant Contact BRUCE PROTHRO
Correspondent
Arthrocare Corp.
595 N. Pastoria Ave.
Sunnyvale,  CA  94085
Correspondent Contact BRUCE PROTHRO
Regulation Number878.4400
Classification Product Code
GEI  
Date Received01/06/2000
Decision Date 02/04/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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