510(k) K813027

STERILE IRRIGATING SYRINGES, KITS,TRAY by Welcon, Inc. — Product Code KYZ

K813027 is an FDA 510(k) premarket notification submitted by Welcon, Inc. for the device "STERILE IRRIGATING SYRINGES, KITS,TRAY". The FDA issued a decision of Substantially Equivalent on November 20, 1981. The device falls under product code KYZ (Syringe, Irrigating (Non Dental)), a Class I device regulated under 21 CFR 880.6960. Welcon, Inc. has at least 7 other 510(k) clearances on record.