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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 K914252
Device Name ASCENTEC MEDICZAL SYSTEMS LAPAROSCOPIC ELECTRODE
Applicant
Ascentec Medical Systems
2930 Blaisdell Ave. S.
Minneapolis,  MN  55408
Applicant Contact PAUL C SMITH
Correspondent
Ascentec Medical Systems
2930 Blaisdell Ave. S.
Minneapolis,  MN  55408
Correspondent Contact PAUL C SMITH
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/23/1991
Decision Date 12/13/1991
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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