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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 K080187
Device Name OLSEN MEDICAL SINGLE USE BAYONET BIPOLAR IRRIGATING FORCEPS
Applicant
Olsen Medical
3001 W. Kentucky St.
Louisville,  KY  40211
Applicant Contact JOHN P WATERS
Correspondent
Olsen Medical
3001 W. Kentucky St.
Louisville,  KY  40211
Correspondent Contact JOHN P WATERS
Regulation Number878.4400
Classification Product Code
GEI  
Date Received01/25/2008
Decision Date 05/09/2008
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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