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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 K940909
Device Name ELECTROSURGICAL MONOPOLAR HANDSWITCHING PENCIL W/REMOVABLE BLADE
Applicant
Debusk Technology Corp.
200 Debusk Ln.
Powell,  TN  37849
Applicant Contact DEBRA F MANNING
Correspondent
Debusk Technology Corp.
200 Debusk Ln.
Powell,  TN  37849
Correspondent Contact DEBRA F MANNING
Regulation Number878.4400
Classification Product Code
GEI  
Date Received02/23/1994
Decision Date 03/30/1994
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
Recalls CDRH Recalls
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