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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 K061975
Device Name PLASMASEAL OPEN FORCEPS, MODELS 2103PK AND 91701PK
Applicant
Acmi Corporation
136 Tpke. Rd.
Southborough,  MA  01772
Applicant Contact TERRENCE E SULLIVAN
Correspondent
Acmi Corporation
136 Tpke. Rd.
Southborough,  MA  01772
Correspondent Contact TERRENCE E SULLIVAN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received07/13/2006
Decision Date 08/10/2006
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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