510(k) K982435

IRRIGATION SYRINGE KIT by Sub-Q, Inc. — Product Code KYZ

K982435 is an FDA 510(k) premarket notification submitted by Sub-Q, Inc. for the device "IRRIGATION SYRINGE KIT". The FDA issued a decision of Substantially Equivalent on November 6, 1998. The device falls under product code KYZ (Syringe, Irrigating (Non Dental)), a Class I device regulated under 21 CFR 880.6960. Sub-Q, Inc. has at least 1 other 510(k) clearance on record.