ROCKET SURGICAL SKIN MARKING PEN— 510(k) K912730

Name: FDA 510(k) clearance K912730
Creator: U.S. Food and Drug Administration
Published: 1991-11-07

Substantially Equivalent

West Texas Lighthouse For the Blind

FDA 510(k) clearance K912730 for ROCKET SURGICAL SKIN MARKING PEN, Substantially Equivalent on 1991-11-07. Applicant: West Texas Lighthouse For the Blind. Device class: 1.

Clearance details

Applicant: West Texas Lighthouse For the Blind
Product code: Code FZZ
Device class: Class 1
Regulation: 21 CFR 878.4660
Advisory panel: General, Plastic Surgery
Date received: 1991-06-20
Decision date: 1991-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Angelo, TX, US

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K042555 — SURGICHIP TAG SURGICAL MARKER2004-11-09
K915066 — DISPOSABLE SKIN MARKER1992-05-14
K914759 — BLOOM TRANSPARENT STENCIL1992-04-21
K905143 — SKIN MARKER1991-02-06
K904559 — QUALTEX SKIN MARKER1990-12-13

Data sourced from openFDA. This site is unofficial and independent of the FDA.