510(k) K853402

E-Z-GUARD MOUTHPIECE by E-Z-Em, Inc. — Product Code BYP

K853402 is an FDA 510(k) premarket notification submitted by E-Z-Em, Inc. for the device "E-Z-GUARD MOUTHPIECE". The FDA issued a decision of Substantially Equivalent on October 23, 1985. The device falls under product code BYP (Mouthpiece, Breathing), a Class I device regulated under 21 CFR 868.5620. E-Z-Em, Inc. has at least 10 other 510(k) clearances on record.