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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 K020031
Device Name EN-BLOC BIOPSY SYSTEM, MODELS 777-110, 777-120, 770-001, 777002, 777-006, 777-301, 777-302
Applicant
Neothermia Corp.
One Apple Hill Suite 316
Natick,  MA  01760
Applicant Contact SHERRIE COVAL-GOLDSMITH
Correspondent
Neothermia Corp.
One Apple Hill Suite 316
Natick,  MA  01760
Correspondent Contact SHERRIE COVAL-GOLDSMITH
Regulation Number878.4400
Classification Product Code
GEI  
Date Received01/04/2002
Decision Date 03/27/2002
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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