Acutek's Clearpasage
FDA 510(k) K962698 · Acutek Adhesive Specialties, Inc.
510(k) numberK962698
Submission
- Device name
- Acutek's Clearpasage
- Applicant
- Acutek Adhesive Specialties, Inc.
Inglewood, CA, US - Received
- June 17, 1996
- Decision date
- September 9, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LWF – Dilator, Nasal
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.3900
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code LWF
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|---|---|---|---|
| K181219 | OptiPillows EPAP MaskLWF · Traditional | Cpapnea Medical Supply | 08/03/2018SE |
| K120665 | Invent Snoring DeviceLWF · Traditional | Ventus Medical, Inc. | 06/12/2012SE |
| K040491 | Chin-Up StripLWF · Abbreviated | Dale Miller, Inc. - the Chin-Up Company | 09/10/2004SE |
| K982929 | Maxair Nasal Dilator SystemLWF · Traditional | Hnl Technologies | 09/09/1998SE |
| K963326 | Breathe FitLWF · Traditional | Cambridge Assoc. | 02/12/1997SE |
| K962400 | Air Max External Nasal Dilator StripLWF · Traditional | American White Cross, Inc. | 09/09/1996SE |
| K955711 | Breathe Right Nasal StripLWF · Traditional | Cns, Inc. | 05/30/1996SE |
| K954914 | Breathe Right Nasal StripLWF · Traditional | Cns, Inc. | 02/27/1996SE |
| K955233 | Easy Breathing Nasal StripsLWF · Traditional | Corbett Lair, Inc. | 12/21/1995SE |
| K953042 | E-Z BreathersLWF · Traditional | E-Z Kare Good Health Systems, Inc. | 12/08/1995SE |
More from E-Z Kare Good Health Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K974891 | Acutek's Hydrocolloid Wound Dressing, Tib 197013MGP · Traditional | 10/21/1998SE |
| K974892 | Acutek's Hydrocolloid Wound Dressing, Tib 197012MGP · Traditional | 10/13/1998SE |
| K974890 | Acutek's Hydrocolloid Wound Dressing, Tib 997002MGP · Traditional | 10/13/1998SE |
| K951644 | Acutek's ClearpassageLWF · Traditional | 07/03/1995SE |
| K943111 | Transparent DressingMGP · Traditional | 09/12/1994SN |
Questions and answers
When was Acutek's Clearpasage cleared by the FDA?
Acutek's Clearpasage (K962698) received a 510(k) decision of Substantially Equivalent on September 9, 1996, 84 days after the submission was received.
What is the product code of K962698?
The FDA product code is LWF – Dilator, Nasal, a Class I (low risk) device regulated under 21 CFR 874.3900.