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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 K922062
Device Name THE DENVER CAUTERY
Applicant
Denver Splint Co.
6099 S. Quebec St.
Suite 200
Englewood,  CO  80111
Applicant Contact RON SHIPPERT
Correspondent
Denver Splint Co.
6099 S. Quebec St.
Suite 200
Englewood,  CO  80111
Correspondent Contact RON SHIPPERT
Regulation Number878.4400
Classification Product Code
GEI  
Date Received05/04/1992
Decision Date 01/12/1993
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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