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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 K101671
Device Name SINGLE SITE FLEXIBLE BLADELESS OBTURATOR
Applicant
Teleflex Medical, Inc.
2917 WECK DR.
RESEARCH TRIANGLE PARK,  NC  27709
Applicant Contact Angela Bouse
Correspondent
Teleflex Medical, Inc.
2917 WECK DR.
RESEARCH TRIANGLE PARK,  NC  27709
Correspondent Contact Angela Bouse
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received06/14/2010
Decision Date 06/25/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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