SKIN MARKER— 510(k) K905143

Substantially Equivalent

Aesculap, Inc.

FDA 510(k) clearance K905143 for SKIN MARKER, Substantially Equivalent on 1991-02-06. Applicant: Aesculap, Inc.. Device class: 1.

Clearance details

Applicant: Aesculap, Inc.
Product code: Code FZZ
Device class: Class 1
Regulation: 21 CFR 878.4660
Advisory panel: General, Plastic Surgery
Date received: 1990-11-15
Decision date: 1991-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burlingame, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FZZ

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K914759 — BLOOM TRANSPARENT STENCIL1992-04-21
K912730 — ROCKET SURGICAL SKIN MARKING PEN1991-11-07
K904559 — QUALTEX SKIN MARKER1990-12-13

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