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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 K972071
Device Name BOVIE MODEL X40
Applicant
Maxxim Medical
1070 Thornwood Ln.
Dacula,  GA  30211 -3007
Applicant Contact MICHAEL A CLARK
Correspondent
Maxxim Medical
1070 Thornwood Ln.
Dacula,  GA  30211 -3007
Correspondent Contact MICHAEL A CLARK
Regulation Number878.4400
Classification Product Code
GEI  
Date Received06/03/1997
Decision Date 10/21/1997
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
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