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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 K993655
Device Name MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS
Applicant
Xomed, Inc.
6743 Southpoint Dr. N.
Jacksonville,  FL  32216 -0980
Applicant Contact MARTIN D SARGENT
Correspondent
Xomed, Inc.
6743 Southpoint Dr. N.
Jacksonville,  FL  32216 -0980
Correspondent Contact MARTIN D SARGENT
Regulation Number878.4400
Classification Product Code
GEI  
Date Received10/29/1999
Decision Date 12/21/1999
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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