SURGICAL SKIN MARKER— 510(k) K864371

Substantially Equivalent

Myocure, Inc.

FDA 510(k) clearance K864371 for SURGICAL SKIN MARKER, Substantially Equivalent on 1986-11-17. Applicant: Myocure, Inc.. Device class: 1.

Clearance details

Applicant: Myocure, Inc.
Product code: Code FZZ
Device class: Class 1
Regulation: 21 CFR 878.4660
Advisory panel: General, Plastic Surgery
Date received: 1986-11-05
Decision date: 1986-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glendale, CA, 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 Myocure, Inc.

K880345 — CYSTOTOMES/KNIFES1988-05-03
K880346 — CANNULAS1988-05-03
K880347 — ANESTHESIA/RETROBULBAR NEEDLES1988-05-03
K874057 — OPHTHALMIC TIP & BLADE SCALPELS1987-12-23
K874056 — OPHTHALMIC DISPOSABLE BLADES1987-12-22

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