510(k) K980717

UROMED SLING KIT by Uromed Corp. — Product Code KNA

K980717 is an FDA 510(k) premarket notification submitted by Uromed Corp. for the device "UROMED SLING KIT". The FDA issued a decision of Substantially Equivalent on May 22, 1998. The device falls under product code KNA (Instrument, Manual, Specialized Obstetric-Gynecologic), a Class II device regulated under 21 CFR 884.4530. Uromed Corp. has at least 9 other 510(k) clearances on record.