BREATHE RIGHT NASAL STRIP
FDA 510(k) clearance K953772 · decided 1995-10-20
Clearance details
- K-number
- K953772
- Device name
- BREATHE RIGHT NASAL STRIP
- Applicant
- Cns, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-08-14
- Decision date
- 1995-10-20
- Days to decision
- 67 days
- Clearance type
- Traditional
- Product code
- LWF
- Device class
- 1
- Regulation number
- 874.3900
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Chanhassen, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| OptiPillows EPAP Mask (K181219) | Cpapnea Medical Supply | 2018-08-03 |
| INVENT SNORING DEVICE (K120665) | Ventus Medical, Inc. | 2012-06-12 |
| CHIN-UP STRIP (K040491) | Dale Miller, Inc. - the Chin-Up Company | 2004-09-10 |
| MAXAIR NASAL DILATOR SYSTEM (K982929) | Hnl Technologies | 1998-09-09 |
| BREATHE FIT (K963326) | Cambridge Assoc. | 1997-02-12 |
| AIR MAX EXTERNAL NASAL DILATOR STRIP (K962400) | American White Cross, Inc. | 1996-09-09 |
| ACUTEK'S CLEARPASAGE (K962698) | Acutek Adhesive Specialties, Inc. | 1996-09-09 |
| BREATHE RIGHT NASAL STRIP (K955711) | Cns, Inc. | 1996-05-30 |
| BREATHE RIGHT NASAL STRIP (K954914) | Cns, Inc. | 1996-02-27 |
| EASY BREATHING NASAL STRIPS (K955233) | Corbett Lair, Inc. | 1995-12-21 |
| E-Z BREATHERS (K953042) | E-Z Kare Good Health Systems, Inc. | 1995-12-08 |
| BURGET NASAL STENT (K942025) | Bivona Medical Technologies | 1995-10-27 |
Recalls involving this device
No recalls on record reference this clearance.