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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 K082054
Device Name GYRUS ACMI PLASMAKINETIC (PK) SUPERPULSE SYSTEM, MODEL 744000 AND DUAL FOOTSWITCH CONNECTOR CABLE, MODEL 710003
Applicant
Gyrus Acmi, Inc.
136 Turnpike Rd.
Southborough,  MA  01772
Applicant Contact TERRENCE E SULLIVAN
Correspondent
Gyrus Acmi, Inc.
136 Turnpike Rd.
Southborough,  MA  01772
Correspondent Contact TERRENCE E SULLIVAN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received07/21/2008
Decision Date 08/06/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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