510(k) K770812

HANDLES, LIGHT, SURGICAL, STEOILE by Sybron Corp. — Product Code FQP

K770812 is an FDA 510(k) premarket notification submitted by Sybron Corp. for the device "HANDLES, LIGHT, SURGICAL, STEOILE". The FDA issued a decision of Substantially Equivalent on May 23, 1977. The device falls under product code FQP (Lamp, Operating-Room), a Class II device regulated under 21 CFR 878.4580. Sybron Corp. has at least 10 other 510(k) clearances on record.