510(k) K791703

TEW BYPASS INSTRUMENTS & DISSECTING KIT by Edward Weck, Inc. — Product Code GDI

K791703 is an FDA 510(k) premarket notification submitted by Edward Weck, Inc. for the device "TEW BYPASS INSTRUMENTS & DISSECTING KIT". The FDA issued a decision of Substantially Equivalent on October 4, 1979. The device falls under product code GDI (Dissector, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Edward Weck, Inc. has at least 10 other 510(k) clearances on record.