510(k) K891038

VAGINAL RETRACTORS - KRISTELLER, DELEE, BREISKY by Zinnanti Surgical Instruments, Inc. — Product Code HDL

K891038 is an FDA 510(k) premarket notification submitted by Zinnanti Surgical Instruments, Inc. for the device "VAGINAL RETRACTORS - KRISTELLER, DELEE, BREISKY". The FDA issued a decision of Substantially Equivalent on March 17, 1989. The device falls under product code HDL (Retractor, Vaginal), a Class I device regulated under 21 CFR 884.4520. Zinnanti Surgical Instruments, Inc. has at least 10 other 510(k) clearances on record.