Product code LWF
- Device name
- Dilator, Nasal
- Medical specialty
- Ear, Nose, Throat
- Device class
- 1
- Regulation number
- 874.3900
- Review panel
- EN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K181219 | OptiPillows EPAP Mask | Cpapnea Medical Supply | 2018-08-03 |
| K120665 | INVENT SNORING DEVICE | Ventus Medical, Inc. | 2012-06-12 |
| K040491 | CHIN-UP STRIP | Dale Miller, Inc. - the Chin-Up Company | 2004-09-10 |
| K982929 | MAXAIR NASAL DILATOR SYSTEM | Hnl Technologies | 1998-09-09 |
| K963326 | BREATHE FIT | Cambridge Assoc. | 1997-02-12 |
| K962400 | AIR MAX EXTERNAL NASAL DILATOR STRIP | American White Cross, Inc. | 1996-09-09 |
| K962698 | ACUTEK'S CLEARPASAGE | Acutek Adhesive Specialties, Inc. | 1996-09-09 |
| K955711 | BREATHE RIGHT NASAL STRIP | Cns, Inc. | 1996-05-30 |
| K954914 | BREATHE RIGHT NASAL STRIP | Cns, Inc. | 1996-02-27 |
| K955233 | EASY BREATHING NASAL STRIPS | Corbett Lair, Inc. | 1995-12-21 |
| K953042 | E-Z BREATHERS | E-Z Kare Good Health Systems, Inc. | 1995-12-08 |
| K942025 | BURGET NASAL STENT | Bivona Medical Technologies | 1995-10-27 |
| K953772 | BREATHE RIGHT NASAL STRIP | Cns, Inc. | 1995-10-20 |
| K954252 | EASY BREATHING NASAL STRIPS | Corbett Lair, Inc. | 1995-10-18 |
| K951644 | ACUTEK'S CLEARPASSAGE | Acutek Adhesive Specialties, Inc. | 1995-07-03 |
| K921220 | BREATHE RIGHT | Cns, Inc. | 1993-10-07 |
| K904290 | NOZOVENT, NASAL DILATOR | Wpm Intl AB Intl Trade & Managemet Consulting | 1991-08-20 |
| K882131 | NOSE BRACE | Allied Advanced Technologies (Aat) | 1988-07-15 |
| K874089 | BREATHE WITH EEZ (NASAL DILATOR) | Breathe With Eez Corp. | 1987-12-23 |
| K862406 | NOZEES NOSTRIL DILATOR | Nozees Co. | 1986-09-19 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00017276238594 | Clear Passage Nasal Strips | Aso LLC | 2021-11-15 |
| 00017276238549 | Clear Passage Nasal Strips | Aso LLC | 2021-11-11 |
| 00017276238136 | CarePak | Aso LLC | 2021-06-21 |
| 00017276224771 | Rexall | DOLGENCORP, LLC | 2020-09-07 |
| 00017276236927 | Clear Passage | Aso LLC | 2020-08-17 |
| 00017276236910 | Clear Passage | Aso LLC | 2020-08-17 |
| 00011822855617 | Rite Aid Pharmacy | RITE AID CORPORATION | 2020-08-10 |
| 00017276224894 | Core Values | HARMON STORES, INC. | 2020-08-10 |
| 00017276224900 | Core Values | HARMON STORES, INC. | 2020-08-10 |
| 00017276228014 | Core Values | HARMON STORES, INC. | 2020-05-18 |
| 00017276230031 | Core Values | HARMON STORES, INC. | 2020-05-18 |
| 00017276234183 | Clear Passage Nasal Strips | Aso LLC | 2020-04-29 |
| 00017276234190 | Clear Passage Nasal Strips | Aso LLC | 2020-04-29 |
| 00017276232974 | Clear Passage Nasal Strips | Aso LLC | 2020-04-29 |
| 00017276232998 | Clear Passage Nasal Strips | Aso LLC | 2020-04-29 |
| 00017276229929 | Up&Up | TARGET CORPORATION | 2020-02-28 |
| 00017276234923 | Up&Up | TARGET CORPORATION | 2020-02-28 |
| 00011822430500 | Rite Aid Pharmacy | RITE AID CORPORATION | 2020-02-10 |
| 00011822685948 | Rite Aid Pharmacy | RITE AID CORPORATION | 2020-01-30 |
| 00011822729475 | Rite Aid Pharmacy | RITE AID CORPORATION | 2020-01-30 |
| 00017276234800 | Clear Passage | Aso LLC | 2019-12-30 |
| 00017276234817 | Clear Passage | Aso LLC | 2019-12-30 |
| 00011822738828 | RITE AID PHARMACY | RITE AID CORPORATION | 2019-07-01 |
| 00017276232981 | Clear Passage Nasal Strips | Aso LLC | 2019-05-30 |
| 00017276232967 | Clear Passage Nasal Strips | Aso LLC | 2019-05-30 |
| 00017276233827 | InstaClear | Aso LLC | 2019-03-29 |
| 00017276233810 | InstaClear | Aso LLC | 2019-03-29 |
| 00017276233803 | InstaClear | Aso LLC | 2019-03-29 |
| 00017276233797 | InstaClear | Aso LLC | 2019-03-29 |
| 00017276233780 | InstaClear | Aso LLC | 2019-03-29 |