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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 K180630
Device Name PTFE SURGICAL SUTURE
Applicant
Omnia Spa
Via F. Delnevo, 190
Fidenza,  IT 43036
Applicant Contact Roberto Cerioli
Correspondent
THEMA S.r.l.
Via Saragat,5
Imola,  IT 40026
Correspondent Contact Marisa Testa
Regulation Number878.5035
Classification Product Code
NBY  
Date Received03/09/2018
Decision Date 04/06/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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