510(k) K833586

TLS BULB DRAINAGE SYSTEM by Porex Medical — Product Code GCY

K833586 is an FDA 510(k) premarket notification submitted by Porex Medical for the device "TLS BULB DRAINAGE SYSTEM". The FDA issued a decision of Substantially Equivalent on January 30, 1984. The device falls under product code GCY (Apparatus, Suction, Single Patient Use, Portable, Nonpowered), a Class I device regulated under 21 CFR 878.4680. Porex Medical has at least 10 other 510(k) clearances on record.