Class Class II

PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus) (K252820)

K252820 2025-10-03 Special
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Description

PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus) by Internacional Farmacéutica S.A DE C.V, an FDA 510(k) cleared general, plastic surgery device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK252820
Clearance Date2025-10-03
Clearance TypeSpecial
Product CodeGAM
Regulation Number878.4493

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