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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biopsy Needle
510(k) Number K981889
Device Name WORLDWIDE MEDICAL TECHNOLOGIES INTRODUCER NEEDLE
Applicant
WORLDWIDE MEDICAL TECHNOLOGIES, LLC
125 MAIN ST., NORTH
WOODBURY,  CT  06798 -0505
Applicant Contact GARY A LAMOUREUX
Correspondent
WORLDWIDE MEDICAL TECHNOLOGIES, LLC
125 MAIN ST., NORTH
WOODBURY,  CT  06798 -0505
Correspondent Contact GARY A LAMOUREUX
Regulation Number876.1075
Classification Product Code
FCG  
Date Received05/29/1998
Decision Date 07/31/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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