Chin-Up Strip
FDA 510(k) K040491 · Dale Miller, Inc. - the Chin-Up Company
510(k) numberK040491
Submission
- Device name
- Chin-Up Strip
- Applicant
- Dale Miller, Inc. - the Chin-Up Company
Dracula, GA, US - Received
- February 26, 2004
- Decision date
- September 10, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K181219 | OptiPillows EPAP MaskLWF · Traditional | Cpapnea Medical Supply | 08/03/2018SE |
| K120665 | Invent Snoring DeviceLWF · Traditional | Ventus Medical, Inc. | 06/12/2012SE |
| 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 |
| 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 |
Questions and answers
When was Chin-Up Strip cleared by the FDA?
Chin-Up Strip (K040491) received a 510(k) decision of Substantially Equivalent on September 10, 2004, 197 days after the submission was received.
What is the product code of K040491?
The FDA product code is LWF – Dilator, Nasal, a Class I (low risk) device regulated under 21 CFR 874.3900.