510(k) K003015

SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD by Surgical Specialties Corp — Product Code GAN

K003015 is an FDA 510(k) premarket notification submitted by Surgical Specialties Corp for the device "SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD". The FDA issued a decision of Substantially Equivalent on December 15, 2000. The device falls under product code GAN (Suture, Absorbable, Synthetic), a Class II device regulated under 21 CFR 878.4830. Surgical Specialties Corp has at least 10 other 510(k) clearances on record.