Cleared Traditional

K914759 - BLOOM TRANSPARENT STENCIL
(FDA 510(k) Clearance)

K914759 · Freckles Publications, Inc. · General & Plastic Surgery device

Apr 1992

Decision

182d

Days

Class 1

Risk

K914759 is an FDA 510(k) clearance for the BLOOM TRANSPARENT STENCIL. This device is classified as a Marker, Skin (Class I - General Controls, product code FZZ).

Submitted by Freckles Publications, Inc. (Lubbock, US). The FDA issued a Cleared decision on April 21, 1992, 182 days after receiving the submission on October 22, 1991.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4660.

Submission Details

510(k) Number	K914759 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 22, 1991
Decision Date	April 21, 1992
Days to Decision	182 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement