510(k) K955322

PROTEC X-RAY DETECTABLE GAUZE SPONGE by Derivados DE Gasa, S.A. DE C.V. — Product Code GDY

K955322 is an FDA 510(k) premarket notification submitted by Derivados DE Gasa, S.A. DE C.V. for the device "PROTEC X-RAY DETECTABLE GAUZE SPONGE". The FDA issued a decision of Substantially Equivalent on December 19, 1995. The device falls under product code GDY (Gauze/Sponge, Internal, X-Ray Detectable), a Class I device regulated under 21 CFR 878.4450. Derivados DE Gasa, S.A. DE C.V. has at least 1 other 510(k) clearance on record.