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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Drainage, Suprapubic
510(k) Number K864770
Device Name SUCTION TUBE
Applicant
NEW ENGLAND SURGICAL INSTRUMENT CORP.
P.O. BOX 35
83 EAST WATER STREET
ROCKLAND,  MA  02370
Applicant Contact RICHARD M BEANE
Correspondent
NEW ENGLAND SURGICAL INSTRUMENT CORP.
P.O. BOX 35
83 EAST WATER STREET
ROCKLAND,  MA  02370
Correspondent Contact RICHARD M BEANE
Regulation Number876.5090
Classification Product Code
FFA  
Date Received12/05/1986
Decision Date 02/24/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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