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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrosurgical
510(k) Number K881763
Device Name COLORADO NEEDLE ELECTRODE
Applicant
Colorado Biomedical, Inc.
6851 Hwy. 73
Evergreen,  CO  80439
Applicant Contact NEWKIRK, DSC
Correspondent
Colorado Biomedical, Inc.
6851 Hwy. 73
Evergreen,  CO  80439
Correspondent Contact NEWKIRK, DSC
Regulation Number878.4400
Classification Product Code
JOS  
Date Received04/25/1988
Decision Date 06/20/1988
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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