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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 K001161
Device Name ULTRAPEN REUSABLE PENCIL, MODEL 130350 THROUGH 130353, REUSABLE ACCESSORY ELECTRODE KIT (FOR USE WITH ULTRAPEN PENCIL),
Applicant
CONMEDCORP
14603 E. FREMONT AVE.
ENGLEWOOD,  CO  80112
Applicant Contact CHARLES M (MIKE) HART
Correspondent
CONMEDCORP
14603 E. FREMONT AVE.
ENGLEWOOD,  CO  80112
Correspondent Contact CHARLES M (MIKE) HART
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/10/2000
Decision Date 06/07/2000
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
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