Cleared Traditional

TEW BYPASS INSTRUMENTS & DISSECTING KIT

K791703 · Edward Weck, Inc. · General & Plastic Surgery

Oct 1979

Decision

37d

Days

Class 1

Risk

About This 510(k) Submission

K791703 is an FDA 510(k) clearance for the TEW BYPASS INSTRUMENTS & DISSECTING KIT, a Dissector, Surgical, General & Plastic Surgery (Class I — General Controls, product code GDI), submitted by Edward Weck, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 4, 1979, 37 days after receiving the submission on August 28, 1979. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number	K791703 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 28, 1979
Decision Date	October 04, 1979
Days to Decision	37 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—