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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrosurgical, cutting & coagulation & accessories
510(k) Number K153063
Device Name PERCUVANCE PERCUTANEOUS SURGICAL SYSTEM
Applicant
Teleflex Medical, Inc.
3015 Carrington Mill Blvd
Morrisville,  NC  27560
Applicant Contact HOLLY HALLOCK
Correspondent
Teleflex Medical, Inc.
3015 Carrington Mill Blvd
Morrisville,  NC  27560
Correspondent Contact HOLLY HALLOCK
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Codes
GCJ   GDO  
Date Received10/22/2015
Decision Date 04/08/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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