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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Trocar, Gastro-Urology
510(k) Number K980804
Device Name SABRE BT BLUNT0TIP SURGICAL TROCAR
Applicant
Endoscopic Concepts, Inc.
50 Brewster St.
Pawtucket,  RI  02860
Applicant Contact PAMELA PAPINEAU
Correspondent
Endoscopic Concepts, Inc.
50 Brewster St.
Pawtucket,  RI  02860
Correspondent Contact PAMELA PAPINEAU
Regulation Number876.5090
Classification Product Code
FBQ  
Date Received03/02/1998
Decision Date 04/01/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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