About This 510(k) Submission
K983162 is an FDA 510(k) clearance for the PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, PERI-STRIPS-STRIPS, PERI-STRIPS DRY, VASC, a Mesh, Surgical (Class II — Special Controls, product code FTM), submitted by Bio-Vascular, Inc. (St. Paul, US). The FDA issued a Cleared decision on October 9, 1998, 29 days after receiving the submission on September 10, 1998. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.