Name: Predicase
Price: 199 USD

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
Product code	GAM
Device class	Class II
Decision date	Oct 3, 2025
Decision	Substantially Equivalent
Regulation	878.4493

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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

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