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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Absorbable, Synthetic, Polyglycolic Acid
510(k) Number K252820
Device Name PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus)
Applicant
Internacional Farmacéutica S.A DE C.V
Circuito De La Industria Poniente Lote 10-C Colonia Parque
Industrial El Cerrillo
Lerma,  MX 52000
Applicant Contact Alejandro Leonardo von Mohr del Conde
Correspondent
Internacional Farmacéutica S.A DE C.V
Circuito De La Industria Poniente Lote 10-C Colonia Parque
Industrial El Cerrillo
Lerma,  MX 52000
Correspondent Contact Diana Berriozabal
Regulation Number878.4493
Classification Product Code
GAM  
Date Received09/04/2025
Decision Date 10/03/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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