510(k) K803069

SHELL KRATON THERMO-PLASTIC RUBBER COMP. by Warren E. Collins, Inc. — Product Code BYP

K803069 is an FDA 510(k) premarket notification submitted by Warren E. Collins, Inc. for the device "SHELL KRATON THERMO-PLASTIC RUBBER COMP.". The FDA issued a decision of Substantially Equivalent on December 22, 1980. The device falls under product code BYP (Mouthpiece, Breathing), a Class I device regulated under 21 CFR 868.5620. Warren E. Collins, Inc. has at least 10 other 510(k) clearances on record.