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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 K073207
Device Name OLYMPUS ESG-100, MODEL WB991046; OLYMPUS AFU-100, MODEL WB950167
Applicant
Celon AG Medical Instruments
3500 Corporate Pkwy.
Center Valley,  PA  18034
Applicant Contact LAURA STORMS-TYLER
Correspondent
Celon AG Medical Instruments
3500 Corporate Pkwy.
Center Valley,  PA  18034
Correspondent Contact LAURA STORMS-TYLER
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
FEQ  
Date Received11/13/2007
Decision Date 05/08/2008
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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