Cleared Traditional

K921761 - SHAWNEE PRODUCTS KIT II
(FDA 510(k) Clearance)

K921761 · Absentee Shawnee Bandage Group · General & Plastic Surgery

Mar 1993

Decision

338d

Days

Class 1

Risk

K921761 is an FDA 510(k) clearance for the SHAWNEE PRODUCTS KIT II. This device is classified as a Tape And Bandage, Adhesive (Class I — General Controls, product code KGX).

Submitted by Absentee Shawnee Bandage Group (Tecumseh, US). The FDA issued a Cleared decision on March 18, 1993, 338 days after receiving the submission on April 14, 1992.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.5240.

Submission Details

510(k) Number	K921761 FDA.gov
FDA Decision	Cleared SESD
Date Received	April 14, 1992
Decision Date	March 18, 1993
Days to Decision	338 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement