Cleared Traditional

K923319 - SHAWNEE PRODUCT KIT IV
(FDA 510(k) Clearance)

K923319 · Absentee Shawnee Bandage Group · General & Plastic Surgery

Jun 1993

Decision

345d

Days

Class 1

Risk

K923319 is an FDA 510(k) clearance for the SHAWNEE PRODUCT KIT IV. 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 June 17, 1993, 345 days after receiving the submission on July 7, 1992.

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

Submission Details

510(k) Number	K923319 FDA.gov
FDA Decision	Cleared SEKD
Date Received	July 07, 1992
Decision Date	June 17, 1993
Days to Decision	345 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement