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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 K981589
Device Name ELECTROSURGICAL BASKET ELECTRODES ELECTROSURGICAL BASKET ELECTRODES
Applicant
Conway Stuart Medical, Inc.
916 W. Maude Ave.
Sunnyvale,  CA  94086
Applicant Contact THOMAS WEHMAN
Correspondent
Conway Stuart Medical, Inc.
916 W. Maude Ave.
Sunnyvale,  CA  94086
Correspondent Contact THOMAS WEHMAN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received05/04/1998
Decision Date 07/30/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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