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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 K010487
Device Name BIPOLAR PENCIL, MODEL 3901-002, 3900-002
Applicant
Medtronic PS Medical
125 Cremona Dr.
Goleta,  CA  93117
Applicant Contact JANET MCAULEY
Correspondent
Medtronic PS Medical
125 Cremona Dr.
Goleta,  CA  93117
Correspondent Contact JANET MCAULEY
Regulation Number878.4400
Classification Product Code
GEI  
Date Received02/20/2001
Decision Date 05/03/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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