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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K944672
Device Name INSURG LAPTIE NEEDLE DRIVER SUTURING DEVICES
Applicant
BOSTON SCIENTIFIC CORP.
480 PLEASANT ST.
WATERTOWN,  MA  02472 -2407
Applicant Contact SHERI D O'BRIEN
Correspondent
BOSTON SCIENTIFIC CORP.
480 PLEASANT ST.
WATERTOWN,  MA  02472 -2407
Correspondent Contact SHERI D O'BRIEN
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received09/22/1994
Decision Date 12/06/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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