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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 K111262
Device Name ELECTROSURGICAL MONOPOLAR CABLE/ADAPTERS, ELECTROSURGICAL BIPOLAR CABLE/ ADAPTERS, BIPOLAR ELECTROSURGICAL CABLES, MONOP
Applicant
OLSEN MEDICAL
3230 COMMERCE CENTER PLACE
LOUISVILLE,  KY  40211
Applicant Contact NUNIE TABERMEJO
Correspondent
OLSEN MEDICAL
3230 COMMERCE CENTER PLACE
LOUISVILLE,  KY  40211
Correspondent Contact NUNIE TABERMEJO
Regulation Number878.4400
Classification Product Code
GEI  
Date Received05/05/2011
Decision Date 05/23/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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