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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 K052246
Device Name MODIFICATION TO EN-BLOC BIOPSY SYSTEM
Applicant
Neothermia Corporation
One Apple Hill Suite 316
Natick,  MA  01760
Applicant Contact DAVID JACOBS
Correspondent
Neothermia Corporation
One Apple Hill Suite 316
Natick,  MA  01760
Correspondent Contact DAVID JACOBS
Regulation Number878.4400
Classification Product Code
GEI  
Date Received08/17/2005
Decision Date 08/22/2005
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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