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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 K002898
Device Name CURON CONTROL MODULE ELECTROSURGICAL GENERATOR AND ACCESSORIES, MODEL S500-ST
Applicant
CURON MEDICAL, INC.
735 PALOMAR ST.
SUNNYVALE,  CA  94086
Applicant Contact THOMAS C WEHMAN
Correspondent
CURON MEDICAL, INC.
735 PALOMAR ST.
SUNNYVALE,  CA  94086
Correspondent Contact THOMAS C WEHMAN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/18/2000
Decision Date 10/17/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Special
Reviewed by Third Party No
Combination Product No
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