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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 K991855
Device Name CONMED STEALTH NON-STICK ACCESSORY ELECTRODE, MODEL 138XXX
Applicant
Conmedcorp
310 Broad St.
Utica,  NY  13501 -1203
Applicant Contact IRA D DUESLER JR
Correspondent
Conmedcorp
310 Broad St.
Utica,  NY  13501 -1203
Correspondent Contact IRA D DUESLER JR
Regulation Number878.4400
Classification Product Code
GEI  
Date Received06/01/1999
Decision Date 06/15/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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