DERMAMARKER

K863280 · Dermacare Products, Inc. · FZZ · Sep 9, 1986 · General, Plastic Surgery

Device Facts

Record IDK863280
Device NameDERMAMARKER
ApplicantDermacare Products, Inc.
Product CodeFZZ · General, Plastic Surgery
Decision DateSep 9, 1986
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 878.4660
Device ClassClass 1

Regulatory Classification

Identification

A skin marker is a pen-like device intended to be used to write on the patient's skin, e.g., to outline surgical incision sites or mark anatomical sites for accurate blood pressure measurement.

Innolitics
510(k) Summary
Decision Summary
Classification Order
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