510(k) K894489

GYNECOLOGIC EXAMINATION KIT by A & A Medical, Inc. — Product Code HIB

K894489 is an FDA 510(k) premarket notification submitted by A & A Medical, Inc. for the device "GYNECOLOGIC EXAMINATION KIT". The FDA issued a decision of Substantially Equivalent on October 5, 1989. The device falls under product code HIB (Speculum, Vaginal, Nonmetal), a Class II device regulated under 21 CFR 884.4530. A & A Medical, Inc. has at least 10 other 510(k) clearances on record.