510(k) K070964

KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTEM by Welch Allyn, Inc. — Product Code HIB

K070964 is an FDA 510(k) premarket notification submitted by Welch Allyn, Inc. for the device "KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTEM". The FDA issued a decision of Substantially Equivalent on May 18, 2007. The device falls under product code HIB (Speculum, Vaginal, Nonmetal), a Class II device regulated under 21 CFR 884.4530. Welch Allyn, Inc. has at least 10 other 510(k) clearances on record.