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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrode, electrosurgical
510(k) Number K895331
Device Name ELECTROSURGICAL ELECTRODE
Applicant
NEW ENGLAND SURGICAL INSTRUMENT CORP.
P.O. BOX 35
83 EAST WATER STREET
ROCKLAND,  MA  02370
Applicant Contact RICHARD VEANE
Correspondent
NEW ENGLAND SURGICAL INSTRUMENT CORP.
P.O. BOX 35
83 EAST WATER STREET
ROCKLAND,  MA  02370
Correspondent Contact RICHARD VEANE
Regulation Number878.4400
Classification Product Code
JOS  
Date Received08/30/1989
Decision Date 09/15/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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