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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name apparatus, electrosurgical
510(k) Number K895337
Device Name ELECTROSURGICAL COAGULATION SUCTION TUBE
Applicant
NEW ENGLAND SURGICAL INSTRUMENT CORP.
P.O. BOX 35
83 EAST WATER STREET
ROCKLAND,  MA  02370
Applicant Contact RICHARD BEANE
Correspondent
NEW ENGLAND SURGICAL INSTRUMENT CORP.
P.O. BOX 35
83 EAST WATER STREET
ROCKLAND,  MA  02370
Correspondent Contact RICHARD BEANE
Regulation Number878.4400
Classification Product Code
HAM  
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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