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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 K031564
Device Name CSS
Applicant
Medical Scientific, Inc.
125 John Hancock Rd.
Taunton,  MA  02780
Applicant Contact PAUL NARDELLA
Correspondent
Medical Scientific, Inc.
125 John Hancock Rd.
Taunton,  MA  02780
Correspondent Contact PAUL NARDELLA
Regulation Number878.4400
Classification Product Code
GEI  
Date Received05/19/2003
Decision Date 10/07/2003
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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