510(k) K921077

DISPOSABLE INTUBATION KITS by Coast Medical Corp. — Product Code BTR

K921077 is an FDA 510(k) premarket notification submitted by Coast Medical Corp. for the device "DISPOSABLE INTUBATION KITS". The FDA issued a decision of Substantially Equivalent on August 25, 1992. The device falls under product code BTR (Tube, Tracheal (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5730. Coast Medical Corp. has at least 10 other 510(k) clearances on record.