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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 K030819
Device Name PLASMAJET SYSTEM
Applicant
Plasma Surgical, Ltd.
18, Grosvenor St.
London,  GB W1K 4QQ
Applicant Contact PETER F GIBSON
Correspondent
Plasma Surgical, Ltd.
18, Grosvenor St.
London,  GB W1K 4QQ
Correspondent Contact PETER F GIBSON
Regulation Number878.4400
Classification Product Code
GEI  
Date Received03/14/2003
Decision Date 08/05/2004
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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