CAPHOSOL
FDA 510(k) clearance K030802 · decided 2003-11-25
Clearance details
- K-number
- K030802
- Device name
- CAPHOSOL
- Applicant
- Inpharma A.S.
- Decision
- Substantially Equivalent
- Date received
- 2003-03-13
- Decision date
- 2003-11-25
- Days to decision
- 257 days
- Clearance type
- Traditional
- Product code
- LFD
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Northborough, MA, US
- Third-party review
- No
- Expedited review
- No
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| Oral-B Dry Mouth Oral Rinse (K203567) | The Procter & Gamble Company | 2021-04-05 |
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| CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray (K181839) | Oralabs, Inc. | 2019-11-21 |
| MucoPEG (K190144) | Sunbio, Inc. | 2019-11-05 |
| SmartMouth DryMouth Oral Rinse (K181194) | Triumph Pharmaceuticals, Inc. | 2019-02-15 |
| Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray (K180680) | Laclede, Inc. | 2018-10-11 |
Recalls involving this device
No recalls on record reference this clearance.