510(k) K771551

I.V. PREP & CARE KIT by Jelco Laboratories — Product Code FRL

K771551 is an FDA 510(k) premarket notification submitted by Jelco Laboratories for the device "I.V. PREP & CARE KIT". The FDA issued a decision of Substantially Equivalent on October 4, 1977. The device falls under product code FRL (Fiber, Medical, Absorbent), a Class I device regulated under 21 CFR 880.5300. Jelco Laboratories has at least 10 other 510(k) clearances on record.