ACUTEK'S CLEARPASSAGE— 510(k) K951644

Name: FDA 510(k) clearance K951644
Creator: U.S. Food and Drug Administration
Published: 1995-07-03

Substantially Equivalent

Acutek Adhesive Specialties, Inc.

FDA 510(k) clearance K951644 for ACUTEK'S CLEARPASSAGE, Substantially Equivalent on 1995-07-03. Applicant: Acutek Adhesive Specialties, Inc.. Device class: 1.

Clearance details

Applicant: Acutek Adhesive Specialties, Inc.
Product code: Code LWF
Device class: Class 1
Regulation: 21 CFR 874.3900
Advisory panel: Ear, Nose, Throat
Date received: 1995-04-10
Decision date: 1995-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Inglewood, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LWF

view all

K181219 — OptiPillows EPAP Mask2018-08-03
K120665 — INVENT SNORING DEVICE2012-06-12
K040491 — CHIN-UP STRIP2004-09-10
K982929 — MAXAIR NASAL DILATOR SYSTEM1998-09-09
K963326 — BREATHE FIT1997-02-12

More clearances from Acutek Adhesive Specialties, Inc.

view all

K974891 — ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 1970131998-10-21
K974890 — ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 9970021998-10-13
K974892 — ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 1970121998-10-13
K962698 — ACUTEK'S CLEARPASAGE1996-09-09
K943111 — TRANSPARENT DRESSING1994-09-12

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