Cleared Traditional

K912730 - ROCKET SURGICAL SKIN MARKING PEN
(FDA 510(k) Clearance)

K912730 · West Texas Lighthouse For the Blind · General & Plastic Surgery device

Nov 1991

Decision

140d

Days

Class 1

Risk

K912730 is an FDA 510(k) clearance for the ROCKET SURGICAL SKIN MARKING PEN. This device is classified as a Marker, Skin (Class I - General Controls, product code FZZ).

Submitted by West Texas Lighthouse For the Blind (San Angelo, US). The FDA issued a Cleared decision on November 7, 1991, 140 days after receiving the submission on June 20, 1991.

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

Submission Details

510(k) Number	K912730 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 20, 1991
Decision Date	November 07, 1991
Days to Decision	140 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement