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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
510(k) Number K173922
Device Name C-PTFETM Surgical Suture
Applicant
Cp Medical, Inc.
1775 Corporate Dr.
Suite 150
Norcross,  GA  30093
Applicant Contact John Hartigan
Correspondent
Cp Medical, Inc.
1775 Corporate Dr.
Suite 150
Norcross,  GA  30093
Correspondent Contact John Hartigan
Regulation Number878.5035
Classification Product Code
NBY  
Date Received12/26/2017
Decision Date 03/26/2018
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
Predetermined Change
Control Plan Authorized		 No
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