Cleared Traditional

K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTH

K970441 · Medi-Flex Hospital Products, Inc. · General & Plastic Surgery
May 1997
Decision
93d
Days
Class 1
Risk

About This 510(k) Submission

K970441 is an FDA 510(k) clearance for the K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTH, a Strip, Adhesive, Closure, Skin (Class I — General Controls, product code FPX), submitted by Medi-Flex Hospital Products, Inc. (Overland Park, US). The FDA issued a Cleared decision on May 9, 1997, 93 days after receiving the submission on February 5, 1997. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.5240.

Submission Details

510(k) Number K970441 FDA.gov
FDA Decision Cleared SESE
Date Received February 05, 1997
Decision Date May 09, 1997
Days to Decision 93 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code FPX — Strip, Adhesive, Closure, Skin
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.5240