510(k) K992736

WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM by Wallach Surgical Devices, Inc. — Product Code HIB

K992736 is an FDA 510(k) premarket notification submitted by Wallach Surgical Devices, Inc. for the device "WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM". The FDA issued a decision of Substantially Equivalent on September 29, 1999. The device falls under product code HIB (Speculum, Vaginal, Nonmetal), a Class II device regulated under 21 CFR 884.4530. Wallach Surgical Devices, Inc. has at least 10 other 510(k) clearances on record.