FLUOROFILM(R)— 510(k) K933800

Substantially Equivalent

American Custom Medical, Inc.

FDA 510(k) clearance K933800 for FLUOROFILM(R), Substantially Equivalent on 1994-06-24. Applicant: American Custom Medical, Inc.. Device class: 1.

Clearance details

Applicant: American Custom Medical, Inc.
Product code: Code EMX
Device class: Class 1
Regulation: 21 CFR 874.4100
Advisory panel: Ear, Nose, Throat
Date received: 1993-08-04
Decision date: 1994-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lubbock, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EMX

K220326 — PosiSep X BAM Hemostat Dressing/Intranasal Splint2022-11-14
K041446 — NASALCEASE2004-07-01
K000108 — RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 1002000-05-23
K993362 — HYLASINE2000-03-13
K983276 — HYDROFERA BACTERISTATIC NASAL DRESSING1999-09-14

More clearances from American Custom Medical, Inc.

K965205 — TEFGEN - LS1997-04-30
K964656 — TEFGEN GUIDED TISSUE MEMBRANE1997-02-10
K944413 — ACM PTFE SURGICAL MESH1994-11-09
K935137 — TEFGEN-FD1994-08-15

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