LWF — Dilator, Nasal Class I
FDA product code LWF covers "Dilator, Nasal", a Class I medical device regulated under 21 CFR 874.3900. Submissions are reviewed by the Ear, Nose, Throat panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LWF
- Device Class
- Class I
- Regulation Number
- 874.3900
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K181219 | cpapnea medical supply | OptiPillows EPAP Mask | August 3, 2018 |
| K120665 | ventus medical | INVENT SNORING DEVICE | June 12, 2012 |
| K040491 | dale miller, inc. - the chin-up | CHIN-UP STRIP | September 10, 2004 |
| K982929 | hnl technologies | MAXAIR NASAL DILATOR SYSTEM | September 9, 1998 |
| K963326 | cambridge assoc | BREATHE FIT | February 12, 1997 |
| K962400 | american white cross | AIR MAX EXTERNAL NASAL DILATOR STRIP | September 9, 1996 |
| K962698 | acutek adhesive specialties | ACUTEK'S CLEARPASAGE | September 9, 1996 |
| K955711 | cns | BREATHE RIGHT NASAL STRIP | May 30, 1996 |
| K954914 | cns | BREATHE RIGHT NASAL STRIP | February 27, 1996 |
| K955233 | corbett lair | EASY BREATHING NASAL STRIPS | December 21, 1995 |
| K953042 | e-z kare good health systems | E-Z BREATHERS | December 8, 1995 |
| K942025 | bivona medical technologies | BURGET NASAL STENT | October 27, 1995 |
| K953772 | cns | BREATHE RIGHT NASAL STRIP | October 20, 1995 |
| K954252 | corbett lair | EASY BREATHING NASAL STRIPS | October 18, 1995 |
| K951644 | acutek adhesive specialties | ACUTEK'S CLEARPASSAGE | July 3, 1995 |
| K921220 | cns | BREATHE RIGHT | October 7, 1993 |
| K904290 | wpm intl ab intl trade and managemet consulting | NOZOVENT, NASAL DILATOR | August 20, 1991 |
| K882131 | allied advanced technologies (aat) | NOSE BRACE | July 15, 1988 |
| K874089 | breathe with eez | BREATHE WITH EEZ (NASAL DILATOR) | December 23, 1987 |
| K862406 | nozees | NOZEES NOSTRIL DILATOR | September 19, 1986 |