Air Max External Nasal Dilator Strip
FDA 510(k) K962400 · American White Cross, Inc.
510(k) numberK962400
Submission
- Device name
- Air Max External Nasal Dilator Strip
- Applicant
- American White Cross, Inc.
Dayville, CT, US - Received
- June 21, 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
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| K982929 | Maxair Nasal Dilator SystemLWF · Traditional | Hnl Technologies | 09/09/1998SE |
| K963326 | Breathe FitLWF · Traditional | Cambridge Assoc. | 02/12/1997SE |
| K962698 | Acutek's ClearpasageLWF · Traditional | Acutek Adhesive Specialties, 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 |
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| K853558 | Dosimetric Release/Radiation Steriliz. Absorb Gauz · Traditional | 09/05/1985SE |
| K853334 | Non-Adhera Adhesive Pad 3X4NAD · Traditional | 08/21/1985SE |
| K852412 | Non-Adherent PadEFQ · Traditional | 07/29/1985SE |
| K852408 | Extra Large Adhesive StripsKGX · Traditional | 07/29/1985SE |
| K852462 | Tricot Adhesive BandageKGX · Traditional | 07/26/1985SE |
| K850595 | 3 X 4 Non-Adherent Pad · Traditional | 03/11/1985SE |
Questions and answers
When was Air Max External Nasal Dilator Strip cleared by the FDA?
Air Max External Nasal Dilator Strip (K962400) received a 510(k) decision of Substantially Equivalent on September 9, 1996, 80 days after the submission was received.
What is the product code of K962400?
The FDA product code is LWF – Dilator, Nasal, a Class I (low risk) device regulated under 21 CFR 874.3900.