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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 K143299
Device Name Percuvance(R) Percutaneous Surgical System
Applicant
Teleflex Medical, Inc.
2917 Weck Drive
Research Triangle Park,  NC  27709
Applicant Contact Holly Hallock
Correspondent
Teleflex Medical, Inc.
2917 Weck Drive
Research Triangle Park,  NC  27709
Correspondent Contact Holly Hallock
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received11/17/2014
Decision Date 01/21/2015
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
Recalls CDRH Recalls
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