DERMAMARKER— 510(k) K863280

Substantially Equivalent

Dermacare Products, Inc.

FDA 510(k) clearance K863280 for DERMAMARKER, Substantially Equivalent on 1986-09-09. Applicant: Dermacare Products, Inc.. Device class: 1.

Clearance details

Applicant: Dermacare Products, Inc.
Product code: Code FZZ
Device class: Class 1
Regulation: 21 CFR 878.4660
Advisory panel: General, Plastic Surgery
Date received: 1986-08-25
Decision date: 1986-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Louisville, KT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FZZ

K042555 — SURGICHIP TAG SURGICAL MARKER2004-11-09
K915066 — DISPOSABLE SKIN MARKER1992-05-14
K914759 — BLOOM TRANSPARENT STENCIL1992-04-21
K912730 — ROCKET SURGICAL SKIN MARKING PEN1991-11-07
K905143 — SKIN MARKER1991-02-06

More clearances from Dermacare Products, Inc.

K882494 — ELAN-E DISPOSALBE DRAPE1988-07-08
K882421 — INFANT ELECTROSURGICAL DISPERSIVE ELECTRODE1988-06-30
K871910 — SURGITEK DISPOSABLE BIPOLAR CORD1987-06-01
K863279 — SURGI-TEK TUBE POSITIONER1986-09-09
K863278 — SURGI-WIPES1986-09-02

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