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510(k) K951644

ACUTEK'S CLEARPASSAGE by Acutek Adhesive Specialties, Inc. — Product Code LWF

K951644 is an FDA 510(k) premarket notification submitted by Acutek Adhesive Specialties, Inc. for the device "ACUTEK'S CLEARPASSAGE". The FDA issued a decision of Substantially Equivalent on July 3, 1995. The device falls under product code LWF (Dilator, Nasal), a Class I device regulated under 21 CFR 874.3900. Acutek Adhesive Specialties, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 1995
Date Received
April 10, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Nasal
Device Class
Class I
Regulation Number
874.3900
Review Panel
EN
Submission Type

Other clearances by Acutek Adhesive Specialties, Inc.

  • K974891 — ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197013 (October 21, 1998)
  • K974890 — ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 997002 (October 13, 1998)
  • K974892 — ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197012 (October 13, 1998)
  • K962698 — ACUTEK'S CLEARPASAGE (September 9, 1996)
  • K943111 — TRANSPARENT DRESSING (September 12, 1994)

Other clearances for product code LWF

  • K181219 — OptiPillows EPAP Mask (August 3, 2018)
  • K120665 — INVENT SNORING DEVICE (June 12, 2012)
  • K040491 — CHIN-UP STRIP (September 10, 2004)
  • K982929 — MAXAIR NASAL DILATOR SYSTEM (September 9, 1998)
  • K963326 — BREATHE FIT (February 12, 1997)
  • K962400 — AIR MAX EXTERNAL NASAL DILATOR STRIP (September 9, 1996)
  • K962698 — ACUTEK'S CLEARPASAGE (September 9, 1996)
  • K955711 — BREATHE RIGHT NASAL STRIP (May 30, 1996)
  • K954914 — BREATHE RIGHT NASAL STRIP (February 27, 1996)
  • K955233 — EASY BREATHING NASAL STRIPS (December 21, 1995)

FDA data resources