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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name suture, nonabsorbable, synthetic, polyethylene
510(k) Number K153089
Device Name 'cottony' II TAPE, PLEDGETS
Applicant
Teleflex Medical, Inc.
3015 Carrington Mill Blvd
Morrisville,  NC  27560
Applicant Contact Natalie Hichak
Correspondent
Teleflex Medical, Inc.
3015 Carrington Mill Blvd
Morrisville,  NC  27560
Correspondent Contact Natalie Hichak
Regulation Number878.5000
Classification Product Code
GAT  
Subsequent Product Codes
DXZ   GAO   GAP   GAQ   GAR  
GAS   GAW  
Date Received10/26/2015
Decision Date 08/12/2016
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
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